SARS-CoV-2 Clinical Trial
— STORMOfficial title:
RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial
Verified date | April 2021 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 13, 2021 |
Est. primary completion date | April 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, not requiring hospitalization - Age =18 years - Willing to sign the informed consent form - Willing to take study drug or placebo as directed for 21 days Exclusion Criteria: - Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, requiring hospitalization - Suspected or confirmed convalescent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), within the prior 4 weeks - Age <18 years' old - Inability to take medications orally - Inability to provide written consent - Known sensitivity/allergy to doxycycline or tetracyclines - Current use of doxycycline for another indication - Pregnancy - A known diagnosis of myasthenia gravis - History of Clostridium Difficile infection within past 12 months - Sun sensitivity - Individuals using medications which could lower doxycycline levels, including barbiturates, phenytoin, carbamazepine, warfarin - Individuals using isotretinoin |
Country | Name | City | State |
---|---|---|---|
United States | Temple University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death | Days Alive and Out of Hospital (Composite Endpoint) | 21 days | |
Secondary | NP SARS-CoV-2 PCR | Change From Baseline of Nasopharyngeal Luminex NxTAG CoV (Positive/Negative) | 21 days | |
Secondary | SARS-CoV-2 Serum Quantitative Viral Load | Change From Baseline of SARS-CoV-2 Serum Quantitative Viral Load | 21 days | |
Secondary | SARS-CoV-2 IgM/IgG Antibodies | Change From Baseline of SARS-CoV-2 IgM/IgG Antibodies (Positive/Negative) | 21 days | |
Secondary | White Blood Cell Count (WBC) | Change From Baseline of White Blood Count (CBC) K/mm3 | 21 days | |
Secondary | Absolute Lymphocyte Count (ALC) | Change From Baseline of Absolute Lymphocyte Count (ALC) K/mm3 | 21 days | |
Secondary | C-Reactive Protein (CRP) | Change From Baseline of C-Reactive Protein (CRP) mg/dL | 21 days | |
Secondary | N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) | Change From Baseline of N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) pg/mL | 21 days | |
Secondary | High Sensitivity Troponin I (hsTnT) | Change From Baseline of High Sensitivity Troponin I (hsTnT) ng/mL | 21 days | |
Secondary | Tumor Necrosis Factor Alpha (TNF-a) | Change From Baseline of Tumor Necrosis Factor Alpha (TNF-a) | 21 days | |
Secondary | IL-1 | Change From Baseline of IL-1 | 21 days | |
Secondary | IL-1B | Change From Baseline of IL-1B | 21 days | |
Secondary | IL-6 | Change From Baseline of IL-6 | 21 days |
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