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RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM

Sponsor
Temple University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04433078
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
9.7
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
Phase 2

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
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.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)
Primary Purpose:
Treatment
Official Title:
RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial
Actual Study Start Date :
Jun 22, 2020
Actual Primary Completion Date :
Apr 13, 2021
Actual Study Completion Date :
Apr 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Doxycycline

Participants receive 100 MG BID for 21 days

Drug: Doxycycline
100 MG Tablet
Placebo Comparator: Placebo

Participants receive Placebo BID for 21 days

Drug: Placebo
Placebo Tablet

Outcome Measures

Primary Outcome Measures

  1. Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death [21 days]

    Days Alive and Out of Hospital (Composite Endpoint)

Secondary Outcome Measures

  1. NP SARS-CoV-2 PCR [21 days]

    Change From Baseline of Nasopharyngeal Luminex NxTAG CoV (Positive/Negative)

  2. SARS-CoV-2 Serum Quantitative Viral Load [21 days]

    Change From Baseline of SARS-CoV-2 Serum Quantitative Viral Load

  3. SARS-CoV-2 IgM/IgG Antibodies [21 days]

    Change From Baseline of SARS-CoV-2 IgM/IgG Antibodies (Positive/Negative)

  4. White Blood Cell Count (WBC) [21 days]

    Change From Baseline of White Blood Count (CBC) K/mm3

  5. Absolute Lymphocyte Count (ALC) [21 days]

    Change From Baseline of Absolute Lymphocyte Count (ALC) K/mm3

  6. C-Reactive Protein (CRP) [21 days]

    Change From Baseline of C-Reactive Protein (CRP) mg/dL

  7. N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) [21 days]

    Change From Baseline of N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP) pg/mL

  8. High Sensitivity Troponin I (hsTnT) [21 days]

    Change From Baseline of High Sensitivity Troponin I (hsTnT) ng/mL

  9. Tumor Necrosis Factor Alpha (TNF-a) [21 days]

    Change From Baseline of Tumor Necrosis Factor Alpha (TNF-a)

  10. IL-1 [21 days]

    Change From Baseline of IL-1

  11. IL-1B [21 days]

    Change From Baseline of IL-1B

  12. IL-6 [21 days]

    Change From Baseline of IL-6

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Temple University Hospital Philadelphia Pennsylvania United States 19140

Sponsors and Collaborators

  • Temple University

Investigators

  • Principal Investigator: Arthur M Feldman, MD, PhD, Temple University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT04433078
Other Study ID Numbers:
  • The STORM Trial
First Posted:
Jun 16, 2020
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Temple University
Doxycycline
Cytokine Storm
SARS-CoV-2
Additional relevant MeSH terms:
Cytokine Release Syndrome
Doxycycline

Study Results

No Results Posted as of Apr 19, 2021