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

• Status: Withdrawn
• Trial end date: 2021-04-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Treatments: Dipyridamole; Doxycycline

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