A Phase 3 interventional study of Ivermectin and ASP in Covid-19, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Gambia. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-06-04.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Treatment
The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or intervention arm.
The trial is adaptive in design, with the option to change the investigational products should evidence change on the benefits/harms of the interventions being trialed.
Cohort 1. Currently index cases with mild COVID-19 or moderate pneumonia will be randomized to ivermectin 0.3-0.4mg/Kg daily for 3 days (arms 1 and 2) or non-identical placebo (arm 3). Index case randomization will also include HH members who will be treated with ivermectin 0.3-0.4mg/Kg daily for 3 days (arm 1) or non-identical placebo (arms 2 and 3). All households will receive a preventative package (containing soap, bleach, cloth facemasks and instructions on their use).
Cohort 2. Patients admitted to hospital meeting WHO criteria for severe COVID-19 pneumonia will be randomized to aspirin 150mg daily or non-identical placebo for 28 days or until hospital discharge (whichever is sooner). Other care will follow National guidelines.
The study will be conducted at multiple sites in The Gambia, with the option to recruit from other West African countries should this be necessary (subject to further local ethical review/s).
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Index case - Individuals ≥ 5 years of age with confirmed COVID19 mild disease or moderate pneumonia defined as:
Household contacts - Individuals ≥ 5 years of age living in the same household with the index cases from cohort 1 will be offered to participate into the study. Living in the same household is defined as those individuals who are planning to sleep in and eat from same 'cooking pot' during the following 2 weeks.
Cohort 2:
Individuals ≥12 years of age with suspected or confirmed COVID-19 associated severe pneumonia defined as signs of pneumonia (fever, cough, dyspnoea or fast breathing) plus one of: oxygen saturation (SpO2) \<90% on room air OR respiratory rate > 30 breaths/minute
Suspected COVID-19 disease is defined as clinically or radiologically suspected as determined by the most senior clinician available:
Exclusion Criteria:
Cohort 2 (aspirin):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Index Case / Household members Ivermectin / Ivermectin (with preventative package)
Drug: Ivermectin
Index Case / Household members Ivermectin / Placebo (with preventative package)
Drug: Ivermectin · Drug: Placebo
Index Case / Household members Placebo / Placebo (with preventative package)
Drug: Placebo
Aspirin 150mg daily for 28 days or until hospital discharge or death (whichever is sooner)
Drug: ASP
Non identical placebo; doses as per above
Drug: Placebo
Ivermectin 0.3-0.4mg/Kg daily for 3 days.
Aspirin 150mg daily for 28 days or until hospital discharge (whichever is sooner)
Non-identical placebo
Cohort 1 Index Case: Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing to severe pneumonia [Time frame 14 days]
Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing within 14 days after recruitment into severe pneumonia (as per WHO definitions of severity, for each age group)
Time frame: 14 days
Cohort 1 Household contacts: Percentage of HH members that get infected with SARS-CoV-2 [Time frame 14 days]
Percentage of HH members that get infected with SARS-CoV-2 during the 14 days following recruitment (defined as those RT-PCR and IgM/IgG negative at day 1 who become positive either by RT-PCR or IgM/IgG by day 14)
Time frame: 14 days
Cohort 2: Percentage of COVID-19 associated severe pneumonia patients worsening their condition [Time frame at discharge or day 28 (whichever is first)]
Percentage of COVID-19 associated severe pneumonia patients meeting the criteria of failure defined as worsening their condition from baseline (on admission) for a period of at least 24 hours, scale as follows: * On or requiring supplemental oxygen given by nasal cannula or face mask to maintain SpO2 within target range * On or requiring non-invasive (eg CPAP or BiPAP) or invasive ventilatory support to maintain SpO2 within target range (or not maintaining SpO2 within target range with supplemental oxygen given by nasal cannula or face mask) * Death during hospitalization
Time frame: up to 28 days
Cohort1 Index cases: Days from recruitment to virological clearance [Time frame 28 days]
- Days from recruitment to virological clearance defined as one negative SARS-CoV2 virus RT-PCRs.
Time frame: 28 days
Days from recruitment until clinical recovery
- Days from recruitment until clinical recovery defined as two consecutive days of no fever (T ≤37.50C) and normal respiratory rate (as per normal range for age and WHO definitions) (only once if day 28 as end of follow-up
Time frame: 28 days
- IgG geometric mean titre (GMT) at day 14 and 28 after recruitment [Time frame 14 days and 28 days]
Time frame: 14 days and 28 days
Household contacts IgG geometric mean titre (GMT) at day 14 after recruitment [Time frame 14 days]
Time frame: 14 days
Percentage of HH members infected that develop COVID19 symptoms [Time frame 14 days]
(defined as those asymptomatic at day 1 that become symptomatic by day 14 (COVID-19 positive either by RT-PCR or IgM/IgG and meet criteria for Cohort 1 index case or cohort 2)
Time frame: 14 days
Cohort 2 - Hours from recruitment to hospital discharge [Time frame at discharge]
Time frame: up to 28 days
- Hours of duration on oxygen supplementation [Time frame at discharge or day 28 (whichever is first)]
Time frame: at discharge or day 28 (whichever is first)
- Death ratio during hospitalization [Time frame at time of death]
Time frame: up to 28 days
- Death ratio at 28 days after enrolment [Time frame 28 days]
Time frame: 28 days
- Death ratio at 90 days after enrolment [Time frame 90 days]
Time frame: 90 days
- Occurrence of clinical thrombotic and embolic events (myocardial infarction, pulmonary embolus, deep venous thrombosis, cerebrovascular accidents). [Time frame 90 days]
Time frame: 90 days
- Occurrence of clinical episodes of gastrointestinal bleeding [Time frame 90 days]
Time frame: 90 days
- Change in CRP and D-Dimer levels between baseline (enrolment) and day 3-5 [Time frame 5 days]
Time frame: enrolment / days 3-5
- Persisting breathlessness at 28 days and 90 days after enrolment [Time frame 28 days/90 days ]
Time frame: at 28 day and at 90 day
- Self-reported health at 28 days and 90 days [Time frame 28 days/ 90 days]
Poor self-reported health assessed by a linear self-reported health scale from the EQ-5D questionnaire in person or by telephone
Time frame: at 28 days and 90 days
Started Jan 2021 (actual). Primary completion is estimated for Mar 2022, 14 months after the start.
Of 285 non-industry phase 3 interventional studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 14 months is above that.
Counting every sponsor, half of 453 studies reached it within 9 months; a quarter within 4 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin
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