CCRC Clinical Studies
Advancing COVID-19 Clinical Research
The CCRC researchers are focused on the advancement of effective therapeutics and interventions for COVID-19 and hope to further the develop treatment and prevention that could be accessible for community members locally and globally, outside of a hospital setting.
The CCRC research teams have conducted a wide range COVID-related clinical studies, including treatment and prophylaxis use of monoclonal antibody infusions/injections and oral antiviral medications. The research participation opportunities that are open for enrollment and that have previously taken place at the CCRC are detailed below for reference. Study sponsors cover all clinical study-related costs. The CCRC is not a hospital and will only have participation from volunteers that fit the study criteria and fully consent to participation.
Interested in volunteering for one of our studies? Contact us to see if you qualify.
A Study For Nirmatrelvir/Ritonavir (Paxlovid) For Adults With COVID-19 And A Compromised Immune System | Pfizer
An interventional efficacy and safety, phase 2, randomized, double-blind, 3-arm study to investigate Nirmatrelvir/Ritonavir in non-hospitalized participants at least 18 years of age with symptomatic COVID-19 who are immunocompromised.
Study Purpose and Summary
Group 1: The purpose of this study is to assess the efficacy, safety, and tolerability of Paxlovid (Nirmatrelvir/Ritonavir) taken for different durations — 5 days (standard of care), 10 days, or 15 days - for adults who have recently tested positive for COVID-19, are symptomatic, and have a compromised immune system.
Group 2: In addition, the study will also evaluate the efficacy and safety of a second treatment course of Paxlovid (Nirmatrelvir/Ritonavir) for adults with a compromised immune system who experience that their COVID-19 is flaring-up (rebounding) within 14 days of having taken a 5-day treatment course of Paxlovid (Nirmatrelvir/Ritonavir).
Eligibility Criteria
- Participants 18 years of age or older
- Willing and able to provide written informed consent to participate
- Have a compromised immune system
- Able to swallow pills
- Agreement to not participate in another clinical trial of an experimental treatment for COVID-19 during the study period
- Group 1:
- Tested positive for COVID-19 infection within the past 5 days
- Have at least 1 symptom associated with COVID-19
- Group 2:
- Tested positive for COVID-19 infection recently
- Have at least 1 symptom associated with COVID-19 that has worsened within 14 days after completion of the initial 5-day course of Paxlovid (Nirmatrelvir/Ritonavir)
Other protocol-defined Inclusion/Exclusion criteria may apply.
To learn more about this trial:
Step 1: Visit ClinicalTrials.gov, identifier NCT05438602, to determine if this study is right for you.
Step 2: If you are interested in volunteering, complete our online survey or contact us by phone or email.
molnupiravir MK-4482-013 — Merck Sharp & Dohme Corp.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19.
The primary objective of this phase 3, multicenter, randomized, double-blind, placebo-controlled study was to determine the efficacy, and safety/tolerability, of molnupiravir (MK-4482) in preventing COVID-19 infection in adults who were residing with a person recently infected with COVID-19.
- Visit ClinicalTrials.gov, identifier NCT04939428, to learn more about the trial
Resolve RSLV-132 - Resolved Therapeutics
A phase 2, double-blind, placebo-controlled study of RSLV-132 in subjects with post-acute COVID-19 (long COVID).
This study’s objective, as a Phase 1 study, was to determine the highest tolerated dose of an investigational cell therapy called DVX201 in patients hospitalized with COVID-19.
- Visit ClinicalTrials.gov, identifier NCT04944121, to learn more about the trial
DVX201 - Deverra Therapeutics, Inc.
A Phase 1 Study of DVX201, an Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19
This study’s objective, as a Phase 1 study, was to determine the highest tolerated dose of an investigational cell therapy called DVX201 in patients hospitalized with COVID-19.
- Visit ClinicalTrials.gov, identifier NCT04900454, to learn more about the trial
casirivimab+imdevimab REGN-2176 - Regeneron Pharmaceuticals, Inc
A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anti-spike SARS-CoV-2 monoclonal antibodies as pre-exposure prophylaxis to prevent COVID-19 in immunocompromised participants.
This study’s primary objective was to evaluate the effect of casirivimab + imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants. .
- Visit ClinicalTrials.gov, identifier NCT05074433, to learn more about the trial
molnupiravir MK-4482-002 — Merck Sharp & Dohme Corp.
A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults with COVID-19.
This study aimed to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. This study enrolled adults who had recently tested positive for SARS-COV-2 and had experienced at least one related mild or moderate symptom. Patients between the ages of 18-59 were required to have at least one pre-existing risk factor to be eligible.
- Visit ClinicalTrials.gov, identifier NCT04668950, to learn more about the trial
- Read Merck’s October 1, 2021 news release: Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study - Merck.com
sotrovimab VIR COMET TAIL — Vir Biotechnology Inc
A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients
This was a phase 3 study that compared the administration route of an intramuscular shot to IV infusion of sotrovimab, a monoclonal antibody with FDA emergency use authorization, for the early treatment of non-hospitalized patients with COVID-19.
- Visit ClinicalTrials.gov, identifier NCT04913675, to learn more about the trial.
- Read Vir’s November 12, 2021 news release: Primary endpoint met in COMET-TAIL Phase 3 trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19 | Vir
REGN 2067 — Regeneron Pharmaceuticals
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients With COVID-19
The REGN 2067 study tested an infusion of REGN-COV2, a combination of two antibodies against SARS-CoV-2, the virus that causes COVID-19, to see whether they could: decrease the amount of virus in the body; decrease the length of time the virus is in the body; and decrease the length and severity of COVID-19 illness.
- Visit ClinicalTrials.gov, identifier NCT04425629, to learn more about the trial.
- Read Regeneron's February 25, 2021 news release: Independent Data Montioring Committee Finds Clear Efficacy For REGEN-COV™ (CASIRIVIMAB WITH IMDEVIMAB) In Phase 3 COVID-19 Outpatient Outcomes Trial
Remdesivir — Gilead Sciences, Inc
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
The primary objectives of this study were to evaluate the efficacy of remdesivir (RDV) in reducing the rate of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
- Visit ClinicalTrials.gov, identifier NCT04501952, to learn more about the trial.
- Read Gilead's June 21, 2021 news release: Gilead’s Veklury® (Remdesivir) Associated With a Reduction in Mortality Rate in Hospitalized Patients With COVID-19 Across Three Analyses of Large Retrospective Real-World Data Sets
StopCOVID2 — Washington University School of Medicine, St Louis
Fluvoxamine for Early Treatment of COVID-19: A Fully-remote, Randomized Placebo Controlled Trial
The purpose of this research study was to determine if a drug called fluvoxamine could be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 was considered investigational, which means the US Food and Drug Administration has not approved it for this use. This study was fully-remote, which means that there is no face-to-face contact; study materials including study drug were shipped to participants' houses. People around the United States and Canada could participate.
- Visit ClinicalTrials.gov, identifier NCT04668950, to learn more about the trial
EIDD 2801 — Ridgeback Therapeutics
This is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19.
This study was Phase 2 of Merck’s MK-4482-002 study, under Ridgeback Therapeutics. Preliminary results show a reduction in infection time with no adverse events reported that were study drug related.
- Visit ClinicalTrials.gov, identifier NCT04405570, to learn more about the trial.
- Read Merck's March 6, 2021 release: Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir
COVID-19 Clinical Research Center
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