Clinical trial NCT04813328: The Effect of Helminth Infection Plus COVID-19 Infection on the Immune Response and Intestinal Microorganisms
Official title: A Pilot Study of the Effects of Helminth Infection and SARS-CoV-2 Seropositivity on Immune Response and the Intestinal Microbiota in India
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2021-03-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible participants will be enrolled from households in the Tiruvallur district, Tamil Nadu, India. Villages and towns in the Tiruvallur district will be selected in consultation with the Department of Public Health, Tamil Nadu. Areas that are known hotspots for COVID-19 will be selected.

Brief summary: This is a pilot, cross-sectional, sample collection study to characterize the immune response and intestinal microorganisms in people with and without COVID-19 antibodies and helminth infection.

Detailed description: This is a pilot, cross-sectional, sample collection study to characterize the immune response and intestinal microbiota in people with and without SARS-CoV-1 antibodies and helminth infection.

A target sample size of 1500 participants aged 5 years or older will undergo a one-time blood and stool collection for SARS-CoV-2 antibody testing, diagnosis of parasitic infections, and experimental studies including transcriptomics (RNA) and microbiome (intestinal microorganisms) characterization. Participants willing to take part in the study will be selected from households in the Tiruvallur district, Tamil Nadu, India. Individual study participation involves a single study visit. Participants will be informed of the results of clinical testing and will be referred for medical care as appropriate.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent.

Exclusion Criteria:

* Poor venous access precluding venipuncture.
* History of any illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the participant's participation in the protocol, or compromise the scientific objectives.

Participants may be co-enrolled in other studies; however study staff should be notified of co-enrollment.

Primary outcomes:
measure: Number of participants with helminth infections
timeFrame: Day 1
measure: Number of participants with SARS-CoV-2 antibodies
timeFrame: Day 1
measure: Number of participants with positive malaria test
timeFrame: Day 1
measure: Average Differential blood count
timeFrame: Day 1
measure: Average Hematocrit levels
timeFrame: Day 1
measure: Number of participants with latent tuberculosis infection
timeFrame: Day 1
measure: Number of participants with Wuchereria bancrofti infection
timeFrame: Day 1
measure: Number of participants with Strongyloides stercoralis infection
timeFrame: Day 1
measure: Number of participants with Ascaris infection
timeFrame: Day 1
measure: Number of participants with hookworm infection
timeFrame: Day 1
measure: Number of participants with Strongyloides infection
timeFrame: Day 1
measure: Number of participants with Trichuris infection
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER)
state: Tamilnadu
Study officials:
affiliation: National Institute for Research in Tuberculosis
name: Subash Babu, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institutes of Health (NIH)
name: P'ng Loke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferris BF, Balasubramanian S, Rajamanickam A, Munisankar S, Dasan B, Menon PA, Loke P, Babu S, Chami GF. Relative contribution of biomedical, demographic, and socioeconomic factors to COVID-19 vaccine receipt in rural India. PLoS One. 2024 Jun 24;19(6):e0305819. doi: 10.1371/journal.pone.0305819. eCollection 2024.