RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM (STORM)
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|ClinicalTrials.gov Identifier: NCT04433078|
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Cytokine Storm SARS-CoV-2||Drug: Doxycycline Drug: Placebo||Phase 2|
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
- Fever (2 points)
- Cough (2 points)
- Dyspnea (2 points)
- Chest pain (1 point)
- Myalgias (1 point)
- Fatigue (1 point)
- GI symptoms (1 point)
- Loss of Smell (1 point)
- Loss of Taste (1 point)
Exposure Criteria: Max 8 points
- Contact with known COVID+ (2 points)
- Healthcare worker -- frequent <6 feet contact for 15 minutes (2 points)
- High-risk work -- supermarket, deli, transportation (2 points)
- Endemic community -- prison/jail/nursing home/LTAC/SNF/rehab/homeless/homeless shelter (2 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) patients to Doxycycline (100 mg BID) or Placebo.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial|
|Actual Study Start Date :||June 22, 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||July 2021|
Participants receive 100 MG BID for 21 days
100 MG Tablet
Placebo Comparator: Placebo
Participants receive Placebo BID for 21 days
- Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death [ Time Frame: 21 days ]Days Alive and Out of Hospital (Composite Endpoint)
- NP SARS-CoV-2 PCR [ Time Frame: 21 days ]Change From Baseline of Nasopharyngeal Luminex NxTAG CoV (Positive/Negative)
- SARS-CoV-2 Serum Quantitative Viral Load [ Time Frame: 21 days ]Change From Baseline of SARS-CoV-2 Serum Quantitative Viral Load
- SARS-CoV-2 IgM/IgG Antibodies [ Time Frame: 21 days ]Change From Baseline of SARS-CoV-2 IgM/IgG Antibodies (Positive/Negative)
- White Blood Cell Count (WBC) [ Time Frame: 21 days ]Change From Baseline of White Blood Count (CBC) K/mm3
- Absolute Lymphocyte Count (ALC) [ Time Frame: 21 days ]Change From Baseline of Absolute Lymphocyte Count (ALC) K/mm3
- C-Reactive Protein (CRP) [ Time Frame: 21 days ]Change From Baseline of C-Reactive Protein (CRP) mg/dL
- N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) [ Time Frame: 21 days ]Change From Baseline of N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) pg/mL
- High Sensitivity Troponin I (hsTnT) [ Time Frame: 21 days ]Change From Baseline of High Sensitivity Troponin I (hsTnT) ng/mL
- Tumor Necrosis Factor Alpha (TNF-a) [ Time Frame: 21 days ]Change From Baseline of Tumor Necrosis Factor Alpha (TNF-a)
- IL-1 [ Time Frame: 21 days ]Change From Baseline of IL-1
- IL-1B [ Time Frame: 21 days ]Change From Baseline of IL-1B
- IL-6 [ Time Frame: 21 days ]Change From Baseline of IL-6
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433078
|Contact: Arthur M Feldman, MD, PhD||215-707-4036||Arthur.Feldman@tuhs.temple.edu|
|Contact: Jamie L Garfield, MD||215-707-5864||Jamie.Garfield@tuhs.temple.edu|
|United States, Pennsylvania|
|Temple University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19140|
|Contact: Arthur M Feldman, MD, PhD 215-707-4036 Arthur.Feldman@tuhs.temple.edu|
|Principal Investigator:||Arthur M Feldman, MD, PhD||Temple University|