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A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID.

NCT05668091 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-02

No results posted yet for this study

Summary

This decentralized trial is a Phase 2, 1:1 randomized, double-blind, superiority, placebo-controlled study in an anticipated 100 non-hospitalized highly symptomatic adult participants with long COVID. It seeks to determine the efficacy, safety, and tolerability of 15 days of Paxlovid (nirmatrelvir/ritonavir), an anti-viral agent, compared with placebo plus ritonavir. The hypothesis is that viral persistence contributes to long COVID in some patients and nirmatrelvir/ritonavir compared with placebo/ritonavir can improve general health status in participants with long COVID. The study will also seek immune signatures associated with treatment response (overseen by Professor Akiko Iwasaki).

The decentralized study does not require site visits, and participants in all 48 states including the District of Columbia, who meet entry criteria can enroll. It is designed to make it convenient to participate. The study drugs will be delivered to the participant's designated address.

Long COVID is also known as post-acute sequelae of SARS-CoV-2 (PASC).

Conditions

Interventions

DRUG

Nirmatrelvir

Two 150 mg tablets taken by mouth every 12 hours.

DRUG

Ritonavir

One 100 mg capsule taken by mouth every 12 hours.

DRUG

Placebo

Two tablets containing placebo matching nirmatrelvir taken by mouth every 12 hours.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Harlan M Krumholz

    lead OTHER

Principal Investigators

  • Harlan M Krumholz, MD, SM · Yale University

  • Akiko Iwasaki, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-14
Primary Completion
2024-04-09
Completion
2024-08-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05668091 on ClinicalTrials.gov