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

Covid19 Clinical Trial

— Palu-COVID  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05012280
• Other study ID #: Palu-COVID
• Status: Terminated
• Start date: September 4, 2021
• Est. completion date: August 17, 2022

Study information

• Verified date: February 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 238
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Malaria
• Paludism

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Institut National De Recherche Biomédical (INRB)	Kinshasa

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	Anti-malaria IgG antibody levels	Anti-malaria IgG antibody levels to other antigens: AMAI, CSPM, GLURP, Pf/RESA55, and IgM antibodies	Day 1
Secondary	The cellular response against malaria	The cellular response against malaria between severe and non-severe COVID-19 cases as measured by IFN-y ELISPOT	Day 1
Secondary	Proportions of acute malaria infection	Proportions of acute malaria infection between severe and non-severe cases of COVID-19 using the Thick Drop and Rapid Diagnostic Test	Day 1
Secondary	Clinical characteristics	Clinical characteristics (symptoms duration) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (type of symptoms) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (height) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (weight) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (blood pressure) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (heart rate) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (respiratory rate) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (temperature) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (spleen size) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical characteristics	Clinical characteristics (free oxygen saturation) of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	Clinical status	Clinical status according to WHO scale of severe and non-severe COVID-19 cases with and without malaria	Day 1
Secondary	SARS-COV-2 specific cellular response	SARS-COV-2 specific cellular (INF-y measure by ELISPOT) immune response of severe and non-severe cases	Day 1
Secondary	SARS-COV-2 specific humoral immune response	SARS-COV-2 specific humoral (Malaria antibodies & antigens measured by Luminex) immune response of severe and non-severe cases	Day 1
Secondary	SARS-COV-2 specific humoral immune response	SARS-COV-2 specific humoral (Covid-19 antibodies & antigens measured by Luminex) immune response of severe and non-severe cases	Day 1
Secondary	Antiviral cytokine release levels	Antiviral cytokine (CXCL10 measure by ELISA) release levels, measured by ELISA and flow cytometry, of peripheral blood monocytes from controls and patients with acute malaria infection	Day 1
Secondary	Antiviral cytokine release levels	Antiviral cytokine (IFN type I measure by ELISA) release levels, measured by ELISA and flow cytometry, of peripheral blood monocytes from controls and patients with acute malaria infection	Day 1