TerminatedNot Applicable

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

Stopped: As the COVID-19 epidemic evolved, presentation of the disease changed substantially. Due to vaccination, increased natural immunity and new variants, there is a substantial decrease in severe cases, making it difficult to recruit new patients.

Democratic Republic of the Congo238 participantsStarted 2021-09-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 judgme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Malaria Antibody Level

Timeframe: Day 1

Trial details

NCT IDNCT05012280

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-17

Results submitted2023-09-20

View on ClinicalTrials.gov More Covid19 trials