Covid19 Clinical Trial - SARS-CoV-2 Immune Responses After COVID-19

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in: • People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study. And • People who have never had COVID-19 (SARS-CoV-2 infection).

Clinical Trial Description

A5404 is a phase IV, open-label study. The objective of A5404 is to evaluate how prior investigational therapy for COVID-19 versus comparator (placebo or active comparator) affects vaccine response. The safety of mRNA COVID-19 vaccines is also explored. Eligible A5404 participants include: Participants of ACTIV-2/A5401 at selected sites who received an investigational therapy or its comparator; and persons without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-A5401 participants). In line with our protocol, for outcome measures related to neutralizing antibodies and adverse events, we further break down the ACTIV-2/A5401 participants into two exposure groups: those who received an active therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous) and those who received Camostat Oral or Placebo. Participants of ACTIV-2/A5401 received study-provided standard dosing of the Moderna mRNA-1273 vaccine, or a community-provided mRNA-based COVID-19 vaccine (e.g., Moderna or Pfizer). Participants in ACTIV-2/A5401 received their mRNA-based COVID-19 vaccine 60-240 days after receiving their last dose of a select ACTIV-2/A5401 investigational therapy, or its comparator. Participants without prior COVID-19 received study-provided standard dosing of the Moderna mRNA-1273 vaccine. The study closed early to accrual on February 25, 2022 due to slow enrollment. Clarification Memo #1 (dated January 11, 2023) reflects decisions to discontinue follow up at study Day 365 instead of following participants to Day 730 after the first dose of vaccine and to reallocate some secondary outcome measures to exploratory outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04952402
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 4
Start date	July 9, 2021
Completion date	January 10, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05047692` - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers	Phase 1
Recruiting	`NCT04395768` - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19	Phase 2
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04506268` - COVID-19 SAFE Enrollment	N/A
Completed	`NCT04508777` - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed	`NCT04961541` - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine	Phase 1/Phase 2
Active, not recruiting	`NCT04546737` - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients	N/A
Terminated	`NCT04581915` - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19	Phase 2/Phase 3
Completed	`NCT04532294` - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants	Phase 1
Not yet recruiting	`NCT04543006` - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19	N/A
Terminated	`NCT04542993` - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy	Phase 2
Completed	`NCT04494646` - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)	Phase 2
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04537663` - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults	Phase 4
Not yet recruiting	`NCT04527211` - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel	Phase 3
Completed	`NCT04387292` - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic	N/A
Not yet recruiting	`NCT05038449` - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19	N/A
Completed	`NCT04979858` - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask	N/A
Completed	`NCT04610502` - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients	Phase 2
Active, not recruiting	`NCT06042855` - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms