A Phase 2 interventional study of Doxycycline and Placebo in Cytokine Storm and SARS-CoV-2, sponsored by Temple University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Temple University · Phase 2, Interventional, and Treatment
The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy respectively. The investigators hypothesize that Doxycycline will will improve survival and reduce morbidity in SARS-CoV-2 infected patients.
A secondary aim is to identify genetic variants that predict either an unusually mild disease or an unusually severe disease - knowledge that can be used to design new and precise medications and to be able to predict patients who might get into early trouble and to therefore hospitalize them.
This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to Doxycycline (100 mg BID) or Placebo and then assess the progression of their disease over the next three weeks with the primary endpoint being days alive and out of the hospital.
The investigators will collect specimens for measurement of viral burden (nasopharyngeal luminex (SARS-CoV-2), SARS-CoV-2 serum quantitative viral load, SARS-CoV-2 IgM/IgG antibodies), markers of inflammation (WBC, ESR, TNFa, IL-1, IL-6, IL-1B), and cardiac dysfunction (CRP, pro-BNP, hsTnT).
Eligibility will be based on history and physical examination findings - collated into a clinical suspicion score. The decision to enroll based on clinical suspicion score rather than confirmed SARS-CoV-2 disease is based on the variable and unacceptably high false negative rate of the nasopharyngeal PCR test for in early disease.
Clinical Suspicion Score: Greater than or equal to 6/20 (at least 4 points of which must be clinical) will be eligible for enrollment.
Clinical Criteria: Max 12 points
Exposure Criteria: Max 8 points
Genetic variants may explain why patients who are infected with SARS-CoV-2 have either a relatively benign or an inappropriately aggressive response to an infectious insult. Medications may be more or less effective in that group of patients harboring genetic variants of a disease-related protein. To better understand this, whole genome sequencing and analysis will be performed on all study patients.
133 studies on the registry are indexed under Cytokine Release Syndrome; 29 are open to participants now.
Browse Cytokine Release Syndrome studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive 100 MG BID for 21 days
Drug: Doxycycline
Participants receive Placebo BID for 21 days
Drug: Placebo
100 MG Tablet
Placebo Tablet
Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death
Days Alive and Out of Hospital (Composite Endpoint)
Time frame: 21 days
NP SARS-CoV-2 PCR
Change From Baseline of Nasopharyngeal Luminex NxTAG CoV (Positive/Negative)
Time frame: 21 days
SARS-CoV-2 Serum Quantitative Viral Load
Change From Baseline of SARS-CoV-2 Serum Quantitative Viral Load
Time frame: 21 days
SARS-CoV-2 IgM/IgG Antibodies
Change From Baseline of SARS-CoV-2 IgM/IgG Antibodies (Positive/Negative)
Time frame: 21 days
White Blood Cell Count (WBC)
Change From Baseline of White Blood Count (CBC) K/mm3
Time frame: 21 days
Absolute Lymphocyte Count (ALC)
Change From Baseline of Absolute Lymphocyte Count (ALC) K/mm3
Time frame: 21 days
C-Reactive Protein (CRP)
Change From Baseline of C-Reactive Protein (CRP) mg/dL
Time frame: 21 days
N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP)
Change From Baseline of N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) pg/mL
Time frame: 21 days
High Sensitivity Troponin I (hsTnT)
Change From Baseline of High Sensitivity Troponin I (hsTnT) ng/mL
Time frame: 21 days
Tumor Necrosis Factor Alpha (TNF-a)
Change From Baseline of Tumor Necrosis Factor Alpha (TNF-a)
Time frame: 21 days
IL-1
Change From Baseline of IL-1
Time frame: 21 days
IL-1B
Change From Baseline of IL-1B
Time frame: 21 days
IL-6
Change From Baseline of IL-6
Time frame: 21 days
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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