Status:
WITHDRAWN
RepurpoSing Old Drugs TO SuppRess a Modern Threat: COVID-19 STORM
Lead Sponsor:
Temple University
Conditions:
Cytokine Storm
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 viru...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04433078
Start Date
June 22 2020
End Date
April 13 2021
Last Update
April 19 2021
Active Locations (1)
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1
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140