Malaria as a Protection Factor Against Severe COVID-19 (Known as SARS-COV-2) in the Democratic Republic of Congo (Palu-COVID)

NCT ID: NCT05012280

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-04
• Study Completion Date: 2022-08-17

Brief Summary

In this study, the investigators will explore the reasons for the apparently lower proportion of severe COVID-19 cases in many sub-Sahara African countries. Indeed, despite fragile health care systems, the burden of COVID-19 on the African continent seems substantially lower than initially feared. Many potential reasons for this discrepancy have been formulated: the different population age structure, experience of African nations with previous pandemics, warmer climate, and genetic preposition. However, another compelling hypothesis is that of trained immunity by endemic pathogens, such as plasmodia. According to this hypothesis, innate immune activation by endemic pathogens would prime a more robust initial innate immune response to SARS-CoV-2 and could therefore protect against severe COVID-19.

To explore this, the investigators propose conducting a case-control study in Kinshasa, in the Democratic Republic of the Congo (DRC). Kinshasa is an area with mixed prevalence of malaria and the area in DRC most affected by COVID-19. In this setting, the investigators will compare cases of severe COVID-19 with controls that have non-severe COVID-19 and that are matched for age, sex, and health zone. The aim is to compare pre-existing immunity against malaria, both cellular and humoral between the two groups.

Conditions

Covid19; Paludism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

To be eligible, study patients must meet the following criteria:

For cases:

• Be at least 18 years of age
• Have an RT-PCR or Antigenic Rapid Test confirmed SARS-CoV-2 infection within 72 hours prior to inclusion.
• Have given informed consent or that of their guardian/ representative to participate in the study.
• Diagnosed as a severe COVID-19 case according to the following criteria:

• Presenting clinical signs of pneumonia: fever, cough, dyspnea or crepitations AND
• Presenting at least one of the following signs:

Respiratory rate > 30 cycles/min OR Severe respiratory distress or SpO2 < 90% on room air

• Be admitted to a care unit for COVID-19
• Residing in the health zone for at least 6 months

For controls:

• Be at least 18 years of age
• Have a PCR or Antigenic Rapid Test-confirmed SARS-CoV-2 infection within 72 hours prior to inclusion
• Have given informed consent to participate in the study
• Diagnosed as a non-severe COVID-19 case according to the following criteria:

• Be asymptomatic OR
• Symptomatic, but no evidence of severe pneumonia Respiratory rate > 30 cycles/min OR Severe respiratory distress or SpO2 < 90% on room air
• Reside in the study health area for at least 6 months
• Recruited within 10 weeks following the matched cases

Exclusion Criteria

To be eligible, study patients cannot meet the following criteria for cases and controls:

• Subject has a contraindication to venipuncture, as determined by clinical judgment
• Subject is vaccinated against SARS-CoV-2
• Subject has been infected with SARS-CoV-2 in the past and now presents with reinfection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut National De Recherche Biomédical (INRB)

Kinshasa, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Palu-COVID

Identifier Type: -

Identifier Source: org_study_id