Covid19Palu-COVIDNCT05012280
Malaria as a Protection Factor Against Severe COVID-19 (Known as SARS-COV-2) in the Democratic Republic of Congo (Palu-COVID)
An observational study of Covid19 and Paludism, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 238 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 4 Sep 2021to 17 Aug 2022
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This case-control study will be conducted in the Republic of Congo in the city of Kinshasa, the epicenter of COVID-19. Kinshasa is a malaria endemic area, the distribution of malaria prevalence is lower in urban areas compared to peri-urban areas. Indeed, the city of Kinshasa is structured in four health districts and sixteen hospitals, distributed in the thirty-five Health Zones for the management of COVID-19. The study will consist of cases and controls: * Cases will be severe COVID-19 cases that will consist of patients hospitalized and recruited in COVID-19 Treatment Centers. * Controls will consist of asymptomatic or symptomatic cases without signs of severity. For each case, two controls will be recruited after having been matched in terms of age, gender and health zone of origin.
Who may be able to join
- 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:
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Institut National De Recherche Biomédical (INRB)
Kinshasa
About this study
Official title: Malaria as a Protection Factor Against Severe COVID-19 in the Democratic Republic of Congo (Palu-COVID)
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.
- Medical subject headings
- COVID-19, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria Antibody Level
Malaria antibody level in severe and non-severe COVID-19 cases. This level will be assessed by measuring the concentration of IgG against Circum Sporozoite Protein (CSP) using the Luminex- MAGPIX, which is expressed in fluorescence intensity.
Analysis of Conditional Maximum Likelihood Estimates.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start4 Sep 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 238 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012280
- Sponsor's protocol ID
- Palu-COVID
- Acronym
- Palu-COVID
- Status last verified
- Oct 2024
- First submitted
- 20 Jul 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria as a Protection Factor Against Severe COVID-19 in the Democratic Republic of Congo (Palu-COVID)
- ClinicalTrials.gov ID
- NCT05012280
- Acronym / sponsor ID
- Palu-COVID / Palu-COVID
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study will be conducted in the Republic of Congo in the city of Kinshasa, the epicenter of COVID-19. Kinshasa is a malaria endemic area, the distribution of malaria prevalence is lower in urban areas compared to peri-urban areas. Indeed, the city of Kinshasa is structured in four health districts and sixteen hospitals, distributed in the thirty-five Health Zones for the management of COVID-19. The study will consist of cases and controls: * Cases will be severe COVID-19 cases that will consist of patients hospitalized and recruited in COVID-19 Treatment Centers. * Controls will consist of asymptomatic or symptomatic cases without signs of severity. For each case, two controls will be recruited after having been matched in terms of age, gender and health zone of origin.
Key inclusion criteria (20 listed)
- 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:
- Respiratory rate > 30 cycles/min OR Severe respiratory distress or SpO2 < 90% on room air
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malaria Antibody Level
Time frame: Day 1
Malaria antibody level in severe and non-severe COVID-19 cases. This level will be assessed by measuring the concentration of IgG against Circum Sporozoite Protein (CSP) using the Luminex- MAGPIX, which is expressed in fluorescence intensity. Analysis of Conditional Maximum Likelihood Estimates.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Paludism, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria Antibody Level (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.