Covid19 Clinical Trial - Immunophenotyping Assessment in a COVID-19 Cohort

Status Completed

Clinical Trial Summary

This surveillance study will collect detailed clinical, laboratory, and radiographic data in coordination with biologic sampling of blood and respiratory secretions and viral shedding in nasal secretions in order to identify immunophenotypic and genomic features of COVID-19 -related susceptibility and/or progression. The aim: for the results obtained from this study to assist in generating hypotheses for effective host-directed therapeutic interventions, to help to prioritize proposals for such interventions, and/or optimize timing for administration of host-response directed therapeutics.

Clinical Trial Description

This is a prospective observational cohort surveillance study of up to 2,000 adult participants hospitalized with known or presumptive COVID-19. Detailed information will be collected regarding patient history and onset of illness upon enrollment. Participants will undergo longitudinal assessments of clinical status and pertinent clinical data (including clinical laboratory values, radiographic findings, medication use, oxygen and ventilatory support requirements, complications, etc.) will be recorded. In parallel, the study will conduct serial biologic sampling for detailed immunophenotyping to provide a comprehensive picture of immune changes that occur throughout the course of infection. The biologic samples to be collected for this observational study include blood, nasal swabs, and endotracheal aspirates. Participants will be followed in hospital through Day 28, unless discharged earlier. If a participant requires an escalation to Intensive Care Unit (ICU)-level care, either within or outside of a dedicated ICU, additional samples will be collected within 24 and 96 hours of care escalation. Convalescent questionnaires and biologic samples will be collected at 3-month intervals up to Month 12 after infection symptom onset, if available. In addition, if a participant is discharged from the hospital prior to Day 28, attempts will be made to collect additional scheduled assessments through Day 28 on an outpatient basis, if feasible. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04378777
Study type	Observational
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase
Start date	May 1, 2020
Completion date	April 21, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Completed	`NCT04527471` - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19	Phase 2
Recruiting	`NCT05584202` - Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants	Phase 2
Completed	`NCT04579549` - Repeat Testing for SARS-CoV-2	N/A
Active, not recruiting	`NCT05547243` - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China	N/A
Recruiting	`NCT04613310` - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19)	N/A
Recruiting	`NCT04747574` - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection	Phase 1
Completed	`NCT04515147` - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19	Phase 2
Terminated	`NCT04447404` - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury	Phase 2
Withdrawn	`NCT04388709` - Interferon Lambda Therapy for COVID-19	Phase 2
Active, not recruiting	`NCT05550142` - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China	N/A
Completed	`NCT04620798` - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students	N/A
Active, not recruiting	`NCT05547256` - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China	N/A
Completed	`NCT04452604` - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed	`NCT04561102` - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed	`NCT05366322` - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Completed	`NCT04526769` - Detecting SARS-CoV-2 in Tears
Terminated	`NCT04958304` - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed	`NCT04690413` - NOWDx Test for the Detection of Antibodies to COVID-19	N/A

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.

Immunophenotyping Assessment in a COVID-19 Cohort — IMPACC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms