NCT04354428

Treatment for COVID-19 in High-Risk Adult Outpatients

Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.

Detailed description

This is a randomized, multi-center, placebo-equivalent (ascorbic acid + folic acid)-controlled, blinded platform trial. Eligible participants will be enrolled and randomized to Hydrocychloroquine (HCQ) + placebo (folic acid), HCQ + azithromycin, lopinavir-ritonavir (LPV/r) or placebo (ascorbic acid + folic acid). Initially, this study will enroll up to 495 eligible adults ( with high risk for Lower respiratory tract infection (LRTI) progression at baseline who are PCR-confirmed SARS-CoV-2 infection (165 per arm). An additional cohort of 135 eligible adults without risk factors for LRTI progression at baseline who are PCR-confirmed SARS-CoV-2 infection will be enrolled for the co-primary virologic outcome. During the 28 study days, participants will take the medication, complete surveys, collect mid nasal swab for viral quantification, and assess symptoms for progression to LRTI. Additional arms will be added should new potential agents be discovered or combination treatments be proposed. In addition, arms may be dropped prior to completion if deemed futile or if there is a safety signal.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	Ascorbic Acid	Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
DRUG	Hydroxychloroquine Sulfate	Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
DRUG	Azithromycin	Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
DRUG	Folic Acid	Eligible participants in a household will receive folic acid and an additional intervention drug
DRUG	Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]	Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy

Timeline

• Start date: 2020-04-16
• Primary completion: 2020-11-03
• Completion: 2020-11-30
• First posted: 2020-04-21
• Last updated: 2022-08-08
• Results posted: 2022-08-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study