TerminatedNCT05593770NECTARUpdated May 2, 2025Results posted

International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

A Phase 2/3 interventional study of Fostamatinib and Placebo in COVID-19, SARS-CoV2 Infection and Coronavirus Infection, sponsored by NEAT ID Foundation. Terminated at 21 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by NEAT ID Foundation · Phase 2/3, Interventional, and Treatment

Why this study was terminated

Following a meeting of the DSMB on 20th September 2023, the recommendation was made to the sponsor on 26th September 2023 that the Fostamatinib arm of the trial ceases enrolment and study medication is discontinued immediately.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

Read the detailed description

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. Between 13 and 40% of patients become hospitalized, up to 30% of those hospitalized require admission for intensive care, and there is a 13% inpatient mortality rate. The reasons for hospitalization include respiratory support, as well as support for failure of other organs, including the heart and kidneys. The risk of thrombotic complications is increased, even when compared to other viral respiratory illnesses, such as influenza. While 82% of hospitalized patients with COVID-19 are ultimately discharged alive, median length of stay is 10-13 days.

Early work in treating COVID-19 has focused on preventing worsening of the initial clinical presentation to prevent hospitalization and disease progression to organ failure and death. Studies conducted under this Master Host Tissue Protocol are expected to extend our knowledge of how to manage patients who are hospitalized for COVID-19 illness. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. This Master Protocol is a randomized, placebo-controlled trial of agents targeting the host response in COVID-19 in hospitalized patients with hypoxemia. The Master Host Tissue Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Our primary outcome is oxygen free days through day 28. This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days.

Conditions studied

COVID-19
SARS-CoV2 Infection
Coronavirus Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 28 is below the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

NEAT ID Foundation is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Hospitalized for COVID-19
≥18 years of age
SARS-CoV-2 infection, documented by:
1. nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
2. documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team).
Hypoxemia, defined as SpO2 \<92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
Symptoms or signs of acute COVID-19, defined as one or more of the following:
1. cough
2. reported or documented body temperature of 100.4 degrees Fahrenheit or greater
3. shortness of breath
4. chest pain
5. infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)

Exclusion criteria

Exclusion Criteria:

Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization
Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)
Pregnancy
Breastfeeding
Prisoners
End-stage renal disease (ESRD) on dialysis
Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient
Known allergy/hypersensitivity to IMP or its excipients

Fostamatinib Arm-Specific Exclusion Criteria:

The following exclusion criteria differ from the master protocol criteria:

Randomized in another trial evaluating fostamatinib in the prior 30 days

Study arm exclusion criteria measured within 24 hours prior to randomization:

AST or ALT ≥ 5 × upper limit of normal (ULN) or ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN
SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization
ANC \< 1000/mL
Patient is anticipated to require a strong CYP3A inhibitor (Atazanavir, Certinib, Clarithromycin, Cobicistat and cobicistat-containing coformulations, Idelalisib,Indinavir, Itraconazole, Ketoconazole, Levoketoconazole, Lonafarnib, Lopinavir, Mifeprostone, Mibefradil, Nefazodone, Nelfinavir, Ombitasvir-paritaprevir-ritonavir plus dasabuvir, Posaconazole, Ribociclib Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Tucatinib, Voriconazole) from randomization to 21 days post-randomization. For a full list of CYP3A4 substrates, please reference this regularly updated list: https://drug-interactions.medicine.iu.edu/MainTable.aspx.
Patient unable to participate or declines participation in the fostamatinib arm.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 28 participants (actual)

Study arms

Experimental
Fostamatinib
An investigational oral spleen tyrosine kinase inhibitor.
Drug: Fostamatinib
Placebo comparator
Placebo
Orange film-coated, plain, bioconvex tablets for fostamatinib. For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.
Drug: Placebo

Interventions

DrugFostamatinib
Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
DrugPlacebo
Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.

What researchers measure

Primary outcomes

Oxygen Free Days Through Day 28
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Time frame: Day 1 to Day 28

Secondary outcomes

In-hospital Mortality
Number of patients who die during hospitalization
Time frame: Day 1 to hospital discharge or Day 90 whichever comes first
Alive and Oxygen Free at Day 14
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Time frame: Day 1 to Day 14
Alive and Oxygen Free at Day 28
Number of patients oxygen free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)
Time frame: Day 1 to Day 28
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Number of patients alive free of new invasive mechanical ventilation at day 28
Time frame: Day 1 to Day 28
28-day Mortality
Number of patients who have died at Day 28
Time frame: Day 28
60-day Mortality
Number of patients who have died at Day 60
Time frame: Day 60
90-day Mortality
Number of participants mortality at Day 90
Time frame: Day 90
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Number of participants who fell within the ordinal scale per the below criteria. A higher score indicates a worse outcome. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Time frame: Day 14
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
The number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Time frame: Day 28
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Time frame: Day 60
Hospital-free Days Through Day 28
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Time frame: Day 1 to Day 28
Ventilator-free Days Through Day 28
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Time frame: Day 1 to Day 28
Respiratory Failure-free Days Through Day 28
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Time frame: Day 1 to Day 28

Results

Posted Nov 5, 2024

Limitations and caveats

Early termination due to DSMB findings of extremely low likelihood of the intervention having a beneficial effect on the primary outcome led to a small number of participants enrolled by international sites and analysis being performed with data from all participants (International and US sites) in the fostamatinib arm of the ACTIV-4 Host Tissue study. Results for all participants in the fostamatinib arm of the ACTIV-4 Host Tissue study are recorded in Clinicaltrials.gov record NCT04924660.

Participant flow

Participant flow — Overall Study
Milestone	Fostamatinib	Placebo
Started	14	14
Completed	12	9
Not completed	2	5

Outcome measures

PrimaryOxygen Free Days Through Day 28

This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Time frame:: Day 1 to Day 28
Reported as:: Mean · days

Oxygen Free Days Through Day 28
days	Fostamatinib	Placebo
Oxygen Free Days Through Day 28	13.4 ± 12.4	14.2 ± 12.1

SecondaryIn-hospital Mortality

Number of patients who die during hospitalization

Time frame:: Day 1 to hospital discharge or Day 90 whichever comes first
Reported as:: Count of participants · Participants

In-hospital Mortality
Participants	Fostamatinib	Placebo
In-hospital Mortality	1	1

SecondaryAlive and Oxygen Free at Day 14

Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Time frame:: Day 1 to Day 14
Reported as:: Count of participants · Participants

Alive and Oxygen Free at Day 14
Participants	Fostamatinib	Placebo
Alive and Oxygen Free at Day 14	10	8

SecondaryAlive and Oxygen Free at Day 28

Number of patients oxygen free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)

Time frame:: Day 1 to Day 28
Reported as:: Count of participants · Participants

Alive and Oxygen Free at Day 28
Participants	Fostamatinib	Placebo
Alive and Oxygen Free at Day 28	11	9

SecondaryAlive and Free of New Invasive Mechanical Ventilation at Day 28

Number of patients alive free of new invasive mechanical ventilation at day 28

Time frame:: Day 1 to Day 28
Reported as:: Count of participants · Participants

Alive and Free of New Invasive Mechanical Ventilation at Day 28
Participants	Fostamatinib	Placebo
Alive and Free of New Invasive Mechanical Ventilation at Day 28	12	11

Secondary28-day Mortality

Number of patients who have died at Day 28

Time frame:: Day 28
Reported as:: Count of participants · Participants

28-day Mortality
Participants	Fostamatinib	Placebo
28-day Mortality	1	1

Secondary60-day Mortality

Number of patients who have died at Day 60

Time frame:: Day 60
Reported as:: Count of participants · Participants

60-day Mortality
Participants	Fostamatinib	Placebo
60-day Mortality	1	2

Secondary90-day Mortality

Number of participants mortality at Day 90

Time frame:: Day 90
Reported as:: Count of participants · Participants

90-day Mortality
Participants	Fostamatinib	Placebo
90-day Mortality	1	3

SecondaryClinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14

Number of participants who fell within the ordinal scale per the below criteria. A higher score indicates a worse outcome. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead

Time frame:: Day 14
Reported as:: Count of participants · Participants

Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Participants	Fostamatinib	Placebo
Score 1	8	6
Score 2	3	1
Score 3	0	1
Score 4	1	3
Score 5	0	0
Score 6	0	0
Score 7	0	0
Score 8	1	1

SecondaryClinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28

The number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead

Time frame:: Day 28
Reported as:: Count of participants · Participants

Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Participants	Fostamatinib	Placebo
Score 1	9	7
Score 2	1	3
Score 3	1	1
Score 4	1	0
Score 5	0	0
Score 6	0	0
Score 7	0	0
Score 8	1	1

SecondaryClinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60

Number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead

Time frame:: Day 60
Reported as:: Count of participants · Participants

Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Participants	Fostamatinib	Placebo
Score 1	7	7
Score 2	2	1
Score 3	0	1
Score 4	1	1
Score 5	0	0
Score 6	0	0
Score 7	0	0
Score 8	1	2

SecondaryHospital-free Days Through Day 28

Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.

Time frame:: Day 1 to Day 28
Reported as:: Mean · days

Hospital-free Days Through Day 28
days	Fostamatinib	Placebo
Spain	21.3 ± 8.2	19.5 ± 12.5
Brazil	-1 ± NA	—
Germany	—	0 ± NA
Italy	14 ± NA	—
South Africa	25.5 ± 3.5	26.5 ± 0.7

SecondaryVentilator-free Days Through Day 28

Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.

Time frame:: Day 1 to Day 28
Reported as:: Mean · days

Ventilator-free Days Through Day 28
days	Fostamatinib	Placebo
Spain	21.3 ± 8.2	19.5 ± 12.5
Brazil	-1 ± NA	—
Germany	—	0 ± NA
Italy	14 ± NA	—
South Africa	25.3 ± 3.5	26.5 ± 0.7

SecondaryRespiratory Failure-free Days Through Day 28

Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.

Time frame:: Day 1 to Day 28
Reported as:: Mean · days

Respiratory Failure-free Days Through Day 28
days	Fostamatinib	Placebo
Spain	21.3 ± 8.2	19.5 ± 12.5
Brazil	-1 ± NA	—
Germany	—	0 ± NA
Italy	14 ± NA	—
South Africa	25.3 ± 3.5	26.5 ± 0.7

Adverse events

Collected over Adverse events will be collected from day 0-60, Mortality will be collected from day 0-90. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Fostamatinib	1/14 (7.1%)	8/14 (57.1%)	8/14 (57.1%)
Placebo	3/14 (21.4%)	5/14 (35.7%)	4/14 (28.6%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Fostamatinib	Placebo
Cardiac failure congestiveCardiac disorders	1/14	0/14
DiarrhoeaGastrointestinal disorders	1/14	0/14
Gastrointestinal haemorrhageGastrointestinal disorders	1/14	0/14
Retroperitoneal haemorrhageGastrointestinal disorders	0/14	1/14
HypertransaminasaemiaHepatobiliary disorders	0/14	1/14
PneumoniaInfections and infestations	0/14	1/14
Pneumonia bacterialInfections and infestations	0/14	1/14
Respiratory tract infectionInfections and infestations	1/14	0/14
Acute kidney injuryRenal and urinary disorders	1/14	0/14
HypoxiaRespiratory, thoracic and mediastinal disorders	1/14	1/14

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Fostamatinib	Placebo
ConstipationGastrointestinal disorders	0/14	1/14
Abdominal pain upperGastrointestinal disorders	1/14	0/14
DiarrhoeaGastrointestinal disorders	0/14	1/14
VomitingGastrointestinal disorders	1/14	0/14
DiscomfortGeneral disorders	0/14	1/14
Injection site phlebitisGeneral disorders	1/14	0/14
SepsisInfections and infestations	1/14	0/14
HyperkalaemiaMetabolism and nutrition disorders	1/14	0/14
InsomniaPsychiatric disorders	0/14	1/14
HaematuriaRenal and urinary disorders	1/14	0/14

Baseline characteristics

Participants were over 18 years old hospitalised with documented SARS-COV-2 infection confirmed by nucleic acid test. Participants were assigned to one either the Fostamatinib the active drug or matching placebo.

Age, Categorical
Age, Categorical(Participants)	Fostamatinib	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	4	3	7
>=65 years	10	11	21

Sex: Female, Male
Sex: Female, Male(Participants)	Fostamatinib	Placebo	Total
Female	6	6	12
Male	8	8	16

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Fostamatinib	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	2	4
White	10	12	22
More than one race	0	0	0
Unknown or Not Reported	2	0	2

Region of Enrollment
Region of Enrollment(participants)	Fostamatinib	Placebo	Total
Brazil	1	0	1
South Africa	2	3	5
Italy	1	1	2
Germany	0	1	1
Spain	10	9	19

Study locations

21 sites

Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Hospital Federal dos Servidores do Estado
Rio De Janeiro, Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio De Janeiro, Brazil
University Hospital Bonn
Bonn, Germany
University of Frankfurt
Frankfurt, Germany
Ente Ospedaliero Ospedali Galliera
Genova, Italy
San Paolo Hospital - ASST Santi Paolo e Carlo
Milan, Italy
San Raffaele Turro Hospital
Milan, Italy
University of Milan
Milan, Italy
Worthwhile Clinical Trials (WWCT Lakeview Hospital)
Benoni, South Africa
Clinical HIV Research Unit - Helen Joseph Hospital (WITS CHRU)
Johannesburg, South Africa
Global Clinical Trials (Pty) Ltd
Pretoria, South Africa
Hospital Clinic Barcelona
Barcelona, Villarroel, Spain
Hospital General Universitario de Elche
Alicante, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Fundacion Alcorcon
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Universidad de Valladolid - Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain

References and documents

Study documents

Protocol and statistical analysis plan · Oct 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05593770
Lead sponsor: NEAT ID Foundation
Responsible party: Sponsor
First posted: Oct 25, 2022
Start date: Oct 27, 2022
Primary completion: Dec 14, 2023
Completion: Dec 14, 2023
Results posted: Nov 5, 2024
Last update: May 2, 2025

Study contacts

Anton Pozniak, Prof

principal investigator · NEAT ID

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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