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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04433078
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

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
Cytokine Storm SARS-CoV-2 Drug: Doxycycline Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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.
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 : June 22, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death [ Time Frame: 21 days ]
    Days Alive and Out of Hospital (Composite Endpoint)


Secondary Outcome Measures :
  1. NP SARS-CoV-2 PCR [ Time Frame: 21 days ]
    Change From Baseline of Nasopharyngeal Luminex NxTAG CoV (Positive/Negative)

  2. SARS-CoV-2 Serum Quantitative Viral Load [ Time Frame: 21 days ]
    Change From Baseline of SARS-CoV-2 Serum Quantitative Viral Load

  3. SARS-CoV-2 IgM/IgG Antibodies [ Time Frame: 21 days ]
    Change From Baseline of SARS-CoV-2 IgM/IgG Antibodies (Positive/Negative)

  4. White Blood Cell Count (WBC) [ Time Frame: 21 days ]
    Change From Baseline of White Blood Count (CBC) K/mm3

  5. Absolute Lymphocyte Count (ALC) [ Time Frame: 21 days ]
    Change From Baseline of Absolute Lymphocyte Count (ALC) K/mm3

  6. C-Reactive Protein (CRP) [ Time Frame: 21 days ]
    Change From Baseline of C-Reactive Protein (CRP) mg/dL

  7. 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

  8. High Sensitivity Troponin I (hsTnT) [ Time Frame: 21 days ]
    Change From Baseline of High Sensitivity Troponin I (hsTnT) ng/mL

  9. Tumor Necrosis Factor Alpha (TNF-a) [ Time Frame: 21 days ]
    Change From Baseline of Tumor Necrosis Factor Alpha (TNF-a)

  10. IL-1 [ Time Frame: 21 days ]
    Change From Baseline of IL-1

  11. IL-1B [ Time Frame: 21 days ]
    Change From Baseline of IL-1B

  12. IL-6 [ Time Frame: 21 days ]
    Change From Baseline of IL-6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Arthur M Feldman, MD, PhD Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04433078    
Other Study ID Numbers: The STORM Trial
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents