NCT04363866

Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)

A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.

Detailed description

A total of 40 participants are planned for enrollment. Those enrolled into this study will be randomized 1:1 to receive either hydroxychloroquine or placebo control. Participants will receive their study intervention for 5 days, after which they will be considered off protocol- directed therapy and receive medical management of their disease according to institutional standards. Participants may be followed for up to 180 days from initiating protocol therapy for clinical outcome, after which they will discontinue study participation.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine is more polar, less lipophilic, and has more difficulty diffusing across cell membranes than the parent compound, chloroquine. These characteristics result in hydroxychloroquine having a longer half-life, comparatively lower toxicity to chloroquine, as well as fewer concerns pertaining to drug-drug interactions
DRUG	Placebo	A placebo is a pill that looks like the study drug but has no real medicine in it.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-03-01
• Completion: 2021-09-01
• First posted: 2020-04-27
• Last updated: 2020-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study