Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence

Official title

Characterizing SARS-CoV-2 Persistence in Host Reservoirs, Post-viral Sequelae, and Associations With Host and Viral Determinants in a Cohort of Convalescent COVID-19 Cases

Overview

The 2019-2020 COVID-19 pandemic is the largest outbreak in recent history. It is not known how long after someone gets sick with COVID-19 and recovers that they can still infect other people. It is also not known how quickly people make antibodies against the virus, which help clear infection from the body. The investigators will enroll 300 people who had COVID-19 based on lab testing or confirmed exposure to participate. An additional 25 participants who have never tested positive for COVID and have not had the vaccine will be enrolled as negative controls. Participants will complete a survey at enrollment. The investigators will also collect blood, nose swab, saliva, stool, semen, and breast milk to test for the virus. The investigators will ask participants to complete a survey and give specimens up to 12 times over 24 months. This information will be used to study how long the virus can live in different parts of the body, antibody development, and post-infectious complications. The investigators hope that this information will allow medical and public health providers to make recommendations to better care for patients in the convalescent phase of COVID-19 infection.

Detailed description

This is an observational prospective cohort study of confirmed cases of COVID-19 recruited from communities surrounding New York City. 325 participants will be recruited from NewYork-Presbyterian (NYP)-Columbia hospital, the community using flyers and snowball sampling, and by contacting participants who are already participating in a Columbia University Irving Medical Center (CUIMC) COVID-19 related study and have given consent to be contacted about participation in related research studies. Candidates will be eligible to participate if they have received a laboratory confirmed diagnosis of COVID-19 or were symptomatic and had a known contact with a confirmed case of COVID-19, and are over the age of 7. Participants who were diagnosed empirically due to symptoms and exposure yet test negative by Reverse transcription polymerase chain reaction (RT-PCR) and serology at baseline will not be considered infected with SARS-CoV-2 and may be excluded. Participants will be consented prior to participation in any study activities and will be prospectively followed for 96 weeks. At baseline, an enrollment survey will be administered that includes demographics, comorbidities, and characteristics of their COVID-19 illness (e.g., exposure, symptom onset, symptom duration, severity of symptoms) and will provide blood and host reservoir site samples. Participants will be followed for a 24 month period after symptom onset, with a maximum of 12 visits.

Primary outcome measures

• Duration of SARS-CoV-2 viral persistence in naso/oropharyngeal samples [Time frame: Up to 96 weeks]
• Duration of SARS-CoV-2 viral persistence in stool or rectal swab samples [Time frame: Up to 96 weeks]
• Duration of SARS-CoV-2 viral persistence in semen samples [Time frame: Up to 96 weeks]
• Duration of SARS-CoV-2 viral persistence in breast milk samples [Time frame: Up to 96 weeks]
• Prevalence of cell immune responses [Time frame: Up to 96 Weeks]
• Duration of COVID-19 Symptoms [Time frame: Up to 96 weeks]
• Prevalence of post-viral sequelae [Time frame: Up to 96 weeks]
• Prevalence of SARS-CoV-2 persistence and bacterial/viral community structures [Time frame: Up to 96 weeks]

Eligibility criteria

Inclusion criteria

• Laboratory confirmed SARS-CoV-2 using currently available laboratory testing techniques (e.g.,RT-PCR, Immunoglobulin M (IgM) /IgG) or clinical history compatible with a COVID-19 like illness(fever, cough, shortness of breath).
• Negative participants with no known prior COVID-19 diagnosis or COVID vaccine
• At least 7 years of age
• Participants are eligible to provide semen and breast milk samples if they are 18 years of age or older

Exclusion criteria

• Age <7
• Intercurrent conditions that in the opinion of the investigator would confound the findings of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Columbia University Medical Center — New York

Publications

• Bergantz L, Subra F, Deprez E, Delelis O, Richetta C. Interplay between Intrinsic and Innate Immunity during HIV Infection. Cells. 2019 Aug 17;8(8):922. doi: 10.3390/cells8080922. PMID 31426525
• 2. New York State Department of Health. https://coronavirus.health.ny.gov/countycounty-breakdown-positive-cases. Accessed March 23, 2020
• 3. WHO Coronavirus disease 2019, Situation Report-63
• 4. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare Settings (Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html. Accessed March 23, 2020.
• Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. PMID 32031570
• Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: PMID 32004427
• Severe acute respiratory syndrome (SARS). Wkly Epidemiol Rec. 2003 Mar 21;78(12):81-3. No abstract available. English, French. PMID 12701272
• Chan KH, Poon LL, Cheng VC, Guan Y, Hung IF, Kong J, Yam LY, Seto WH, Yuen KY, Peiris JS. Detection of SARS coronavirus in patients with suspected SARS. Emerg Infect Dis. 2004 Feb;10(2):294-9. doi: 10.3201/eid1002.030610. PMID 15030700

Identifiers

NCT: NCT04448145 · AAAS9722

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗