Trial Outcomes & Findings for Malaria as a Protection Factor Against Severe COVID-19 (Known as SARS-COV-2) in the Democratic Republic of Congo (Palu-COVID) (NCT NCT05012280)
NCT ID: NCT05012280
Last Updated: 2024-10-17
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
238 participants
Primary outcome timeframe
Day 1
Results posted on
2024-10-17
Participant Flow
137 cases and 101 controls were included in the trial. Total paired matched case-controls at the end of study: 95 (95 controls and 95 cases). Baseline characteristics were entered for the matched case-control participants.
Participant milestones
| Measure |
Cases
Cases are severe COVID-19 cases and comprise inpatients recruited from CTCOs.
* Presenting clinical signs of pneumonia: fever, cough, or respiratory difficulties AND
* Presenting at least one of the following:
* Respiratory rate \> 30 breaths/min OR
* Severe respiratory distress (clarification: with oxygen) OR
* SpO2 \< 90% in room air (clarification: without oxygen)
* Be admitted to a care unit for COVID-19 (clarification: hospital)
|
Controls
Controls are asymptomatic or symptomatic cases without signs of severity:
* Asymptomatic OR
* Symptomatic, but without any signs of severe pneumonia:
* Respiratory rate ≤ 30 breaths/min AND
* No severe respiratory distress AND
* SpO2 ≥ 90% in room air
* Recruited within 10 weeks of a matched case
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
101
|
|
Overall Study
COMPLETED
|
137
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Malaria as a Protection Factor Against Severe COVID-19 (Known as SARS-COV-2) in the Democratic Republic of Congo (Palu-COVID)
Baseline characteristics by cohort
| Measure |
Cases
n=95 Participants
Cases are severe COVID-19 cases and comprise inpatients recruited from CTCOs.
* Presenting clinical signs of pneumonia: fever, cough, or respiratory difficulties AND
* Presenting at least one of the following:
* Respiratory rate \> 30 breaths/min OR
* Severe respiratory distress (clarification: with oxygen) OR
* SpO2 \< 90% in room air (clarification: without oxygen)
* Be admitted to a care unit for COVID-19 (clarification: hospital)
|
Controls
n=95 Participants
Controls are asymptomatic or symptomatic cases without signs of severity:
* Asymptomatic OR
* Symptomatic, but without any signs of severe pneumonia:
* Respiratory rate ≤ 30 breaths/min AND
* No severe respiratory distress AND
* SpO2 ≥ 90% in room air
* Recruited within 10 weeks of a matched case
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
54 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
95 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Civil status
Single
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Civil status
Married
|
63 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Civil status
Widow(er)
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Civil status
No information
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Level of education
Illiterate
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Level of education
Primary school degree
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Level of education
Secondary school degree
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Level of education
Higher education/university
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Level of education
No information
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Occupation
No job occupation
|
45 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Occupation
farmer
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Occupation
Maintenance worker
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Occupation
driver
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Occupation
Shopkeeper/Store clerk
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Occupation
Office worker/Public servant
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Occupation
teacher
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Occupation
gardener
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Occupation
worker
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Occupation
technician
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Occupation
other
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Occupation
no information
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Bandalungwa
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Barumbu
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Binza-Meteo
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Binza-Ozone
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Gombe
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Kalamu I
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Kalamu II
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Kasa-Vubu
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Kimbanseke
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Kintambo
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Kisenso
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Lemba
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Limete
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Lingwala
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Makala
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Masina I
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Masina II
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Matete
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Mont-Ngafula I
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Ndjili
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Ngaba
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Ngiri-Ngiri
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Nsele
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Health Zone of Kinshasa
Selembao
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Malaria 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.
Outcome measures
| Measure |
Cases
n=95 Participants
The cases will be severe COVID-19 cases, and will comprise hospitalized patients recruited from COVID-19 Treatment Centers.
|
Controls
n=95 Participants
Controls will consist of asymptomatic or symptomatic COVID-19 cases without signs of severity.
|
|---|---|---|
|
Malaria Antibody Level
|
3.8 fluorescence intensity (log scale)
Interval 2.4 to 4.7
|
3.3 fluorescence intensity (log scale)
Interval 2.6 to 4.5
|
Adverse Events
Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER