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

NCT04433078 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: The STORM Trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytokine Storm; SARS-CoV-2

Keywords

Doxycycline; Cytokine Storm; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death

  Days Alive and Out of Hospital (Composite Endpoint)

  21 days

Secondary Outcomes (12)

• NP SARS-CoV-2 PCR

  21 days

• SARS-CoV-2 Serum Quantitative Viral Load

  21 days

• SARS-CoV-2 IgM/IgG Antibodies

  21 days

• White Blood Cell Count (WBC)

  21 days

• Absolute Lymphocyte Count (ALC)

  21 days

Study Arms (2)

Doxycycline

EXPERIMENTAL

Participants receive 100 MG BID for 21 days

Drug: Doxycycline

Placebo

PLACEBO COMPARATOR

Participants receive Placebo BID for 21 days

Drug: Placebo

Interventions

Doxycycline DRUG

100 MG Tablet

Doxycycline

Placebo DRUG

Placebo Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Cytokine Release Syndrome

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Arthur M Feldman, MD, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 16, 2020
• Study Start: June 22, 2020
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)