Covid-19Phase 3MALCOVNCT04695197
Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso
A Phase 3 study testing Artemether-lumefantrine (AL) and Pyronaridine-artesunate (PA) in people with Covid-19 and Malaria, run by Liverpool School of Tropical Medicine at 2 sites in 2 countries.
Trial summary
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. Read more about this study
- Who is it for?
- Ages 6 months to 100 yearsHealthy volunteers can take part
- What is being tested?
- Artemether-lumefantrine (AL) and Pyronaridine-artesunate (PA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jan 2021to 20 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 months to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Laboratory confirmed SARS-CoV-2 infection, with positive molecular test results within the past 72 hours*
- Aged >=6 months **
- Resident in the study area
- The participant or caretaker is willing and able to give informed consent or assent with parent/guardian informed consent for participation in the study
- Agrees not to self-medicate with chloroquine, hydroxychloroquine or other antimalarials with potential anti-SARS-CoV-2 properties
- Not previously diagnosed with COVID-19
Show all 10Show fewer
- Contactable by phone for follow-up permitting real-time, reliable information
- Uncomplicated malaria, defined as able to take oral medication
- Bodyweight ≥5kg
- Confirmed malaria infection by RDT (pLDH) or microscopy
Who cannot join
- Unwilling or unable to provide informed consent/assent
- The participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results
- Inability/unlikely to be in the study area for the duration of the 28-day follow-up period
- Pregnant or lactating women
- Severe disease requiring parenteral treatment
- Currently receiving, or recently received (within the last 28 days) pyronaridine-artesunate or artemether-lumefantrine
Show all 11Show fewer
- Received chloroquine in the last three days
- Inability/unlikely to be in the study area for the duration of the 42-day follow-up period
- Known hypersensitivity or specific contraindication to the use of any of the study drugs in the treatment arms
- Known chronic kidney disease (signs or symptoms of stage IV renal impairment or receiving dialysis)
- Known liver cirrhosis (Child-Pugh Class B or greater) or signs or symptoms of severe hepatotoxicity
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.
Read the detailed description
Background: In Africa, COVID-19 has the potential to cripple the continent's fragile healthcare systems and be devastating economically. It is unknown whether malaria infection worsens COVID-19, affects the acquisition of protective antibodies against the SARS-CoV-2 virus, or contributes to its onwards spread by resulting in higher viral loads and/or longer duration of viral shedding. It is also unknown if the effective clearance of malaria parasites and/or the choice of antimalarials affects any of these potential associations. His study will determine if the antimalarial pyronaridine, in the fixed-dose combination of pyronaridine-artesunate, has a positive, negative or negligible effect on COVID-19 disease progression or duration of viral carriage and the seroconversion rate to SARS-CoV-2.
Methods: A malaria treatment trial will be conducted nested within a larger observational COVID-19 cohort study in highly malaria-endemic areas in western Kenya and Burkina-Faso. The COVID-19 cohort study consists of approximately 708 newly diagnosed COVID-19 patient of all ages. They will be enrolled from a source population of approximately 4,720 individuals of all ages screened for SARS-CoV-2. It is anticipated that approximately 142 of the 708 cohort participants will be co-infected with malaria. These co-infected participants will be enrolled in the nested malaria treatment trial if they have uncomplicated malaria and are able to take oral medication. They will be randomized to receive either a standard 3-day treatment course of artemether-lumefantrine (the current first-line treatment) or pyronaridine-artesunate, a new highly effective antimalarial combination that is being rolled out as first or second-line treatment in western Kenya and Burkina Faso. All 142 patients will be followed for 42 days and nasal swabs and blood samples taken on days 1, 3, 7, 14, and 28. Malaria smears will be taken on days 3, 7, 14, 21, 28 and 42. The primary endpoint is the rate of SARS-CoV-2 clearance by day-7.
To limit the transmission of SARS-CoV-2, strict adherence to infection prevention and control (IPC) guidelines, including use of personal protection equipment (PPE), and measures for patient transport will be followed as per national guidelines in each country. Written informed consent/assent will be sought.
Partners: This 18-months study is funded by the Bill and Melinda Gates Foundation and is part of a collaboration between the Kenyan Medical Research Institute (KEMRI) in Kenya; the US Centers for Disease Control and Prevention (CDC); the Liverpool School of Tropical Medicine (LSTM); the Ministry of Health, Kenya; the Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso; the Ministry of Health in Burkina Faso, and the London School of Hygiene and Tropical Medicine (LSHTM). LSTM and LSHTM will act as sponsors for the studies in Kenya and Burkina Faso, respectively.
- Being tested
- Artemether-lumefantrine (AL), Pyronaridine-artesunate (PA)
- Medical subject headings
- COVID-19, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine (AL)Drug
Also called Coartem
Current first line treatment of malaria. Dose: Bodyweight (kg) Dose (mg) of artemether + lumefantrine given twice daily for 3 days (total, six doses) 5 to < 15 20 + 120 15 to < 25 40 + 240 25 to < 35 60 + 360 >=35 80 + 480; Twice daily for 3 days (total, six doses)
Pyronaridine-artesunate (PA)Drug
Also called Pyramax
Antimalarial; Dose: Body weight (kg) Dose (mg) of pyronaridine + aresunate given once daily for 3 days (total, three doses) 5 to < 8 60 + 20 8 to <15 120 + 40 15 to <20 180 + 60 20 to <24 kg 180 + 60 24 to <45 360 + 120 45 to <65 540 + 180 >=65 720 + 240; Once-daily for 3 days (total, three doses).
| Study group | Role | What they receive |
|---|---|---|
| Artemether-lumefantrine | Active comparator | Artemether-lumefantrine, standard 3-day antimalarial treatment regimen. Receives: Drug: Artemether-lumefantrine (AL) |
| Pyronaridine-artesunate | Experimental | Pyronaridine-artesunate, standard 3-day antimalarial treatment regimen. Receives: Drug: Pyronaridine-artesunate (PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SARS-CoV-2 clearance
Defined as the proportion of participants with a negative nasal swab on Day 7 after the start of treatment
Measured: by day 7
Secondary outcomes (16)
Median viral load of SARS-CoV-2
Median CT value as detected from mid-nasal swabs by PCR
Measured: by day 14
Cumulative incidence of SARS-CoV-2 clearance
Defined as the proportion of participants with negative nasal swabs
Measured: by days 14, 21 and 28
Time to clearance of nasal SARS-CoV-2
Defined as the number of days to a negative SARS-CoV-2 RNA PCR tests (swabs collected on days 1, 3, 7, 14, 21 and 28)
Measured: by days 1, 3, 7, 14 and 28
Cumulative seroconversion rates (IgG, IgM, IgA)
proportion of antibody negative patients on enrolment who seroconvert
Measured: by days 7, 14, 21 and 28
IgG, IgM, IgA antibody titres against SARS-CoV-2
Geometric mean, maximum, and change from baseline
Measured: by days 7, 14, 21 and 28
IL-6, IL-7, IL-10, TNF-alpha and Interferon-Gamma
median, max and change from baseline
Measured: by days 3, 7, 14 and 28
CRP and angiotensin-2, angiopoietin-1 and angiopoietin-2
median, max and change from baseline
Measured: by days 3, 7, 14 and 28
Genomic responses to SARS-CoV-2 infection
Transcriptional profiling (gene expression) of whole blood and fixed whole blood for T and B cell markers
Measured: by day 28
Cellular immune responses to SARS-CoV-2 infection
T cell responses
Measured: by day 28
The clinical and parasitological antimalarial treatment response
Expressed as the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response. Recrudescence will be differentiated from new infection by genotyping of malaria parasites
Measured: by day 42
COVID-19 disease severity
Defined by a severity index score for COVID-19
Measured: by day 28
COVID-19 disease duration
The proportion of days with symptoms after randomization
Measured: by day 28
COVID-19 fever duration
The proportion of days with a fever after randomization
Measured: by day 28
COVID-19 respiratory symptoms duration
The proportion of days with respiratory symptoms after randomization
Measured: by day 28
COVID-19 disease duration in days
The number of days until symptom clearance
Measured: by day 28
Treatment-related adverse events, serious adverse events, and adverse events resulting in treatment discontinuation
The cumulative proportion of patients with any of these events after the start of treatment
Measured: by day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start8 Jan 2021
- Primary completion1 Nov 2022
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Permuted block randomization
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Groupe de Recherche Action en Sante, Centres for Disease Control and Prevention, Kenya., Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kariuki Simon, PhD, Principal investigator, Kenya Medical Research InstituteSirima Sodiomon, MD, PhD, Principal investigator, Groupe de Recherche Action en Sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695197
- Sponsor's protocol ID
- 20-063
- Other IDs
- 202009642148520
- Acronym
- MALCOV
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will encourage data sharing to ensure that the scientific potential of this study is maximized. The full anonymized research database will be made publicly available as soon as the full study findings have been published or based on any data requests that may occur during the study or analysis is still ongoing. For the databases, we will use a controlled access approach.
Publications
Tangara B, Barsosio HC, Marlais T, Kabore JMT, Tiono AB, Otieno K, Wanjiku M, Achieng M, Onyango ED, Ondieki ED, Aura H, Odawo T, Allen DJ, Hannan L, Tetteh KK, Soulama I, Ouedraogo A, Serme SS, Soulama BI, Barry A, Badoum ES, Matthewman J, Brazal-Monzo H, Canizales J, Drabko A, Wu W, Kariuki S, Lesosky M, Sirima SB, Drakeley C, Ter Kuile FO. Artemether-lumefantrine versus pyronaridine-artesunate for the treatment of malaria in patients with mild to moderate COVID-19 in Kenya and Burkina Faso: a randomised open-label trial (MALCOV). EClinicalMedicine. 2026 Jan 3;91:103735. doi: 10.1016/j.eclinm.2025.103735. eCollection 2026 Jan.
PubMed 41552003
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso
- ClinicalTrials.gov ID
- NCT04695197
- Acronym / sponsor ID
- MALCOV / 20-063
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Groupe de Recherche Action en Sante, Centres for Disease Control and Prevention, Kenya., Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.
Detailed description
Background: In Africa, COVID-19 has the potential to cripple the continent's fragile healthcare systems and be devastating economically. It is unknown whether malaria infection worsens COVID-19, affects the acquisition of protective antibodies against the SARS-CoV-2 virus, or contributes to its onwards spread by resulting in higher viral loads and/or longer duration of viral shedding. It is also unknown if the effective clearance of malaria parasites and/or the choice of antimalarials affects any of these potential associations. His study will determine if the antimalarial pyronaridine, in the fixed-dose combination of pyronaridine-artesunate, has a positive, negative or negligible effect on COVID-19 disease progression or duration of viral carriage and the seroconversion rate to SARS-CoV-2.
Methods: A malaria treatment trial will be conducted nested within a larger observational COVID-19 cohort study in highly malaria-endemic areas in western Kenya and Burkina-Faso. The COVID-19 cohort study consists of approximately 708 newly diagnosed COVID-19 patient of all ages. They will be enrolled from a source population of approximately 4,720 individuals of all ages screened for SARS-CoV-2. It is anticipated that approximately 142 of the 708 cohort participants will be co-infected with malaria. These co-infected participants will be enrolled in the nested malaria treatment trial if they have uncomplicated malaria and are able to take oral medication. They will be randomized to receive either a standard 3-day treatment course of artemether-lumefantrine (the current first-line treatment) or pyronaridine-artesunate, a new highly effective antimalarial combination that is being rolled out as first or second-line treatment in western Kenya and Burkina Faso. All 142 patients will be followed for 42 days and nasal swabs and blood samples taken on days 1, 3, 7, 14, and 28. Malaria smears will be taken on days 3, 7, 14, 21, 28 and 42. The primary endpoint is the rate of SARS-CoV-2 clearance by day-7.
To limit the transmission of SARS-CoV-2, strict adherence to infection prevention and control (IPC) guidelines, including use of personal protection equipment (PPE), and measures for patient transport will be followed as per national guidelines in each country. Written informed consent/assent will be sought.
Partners: This 18-months study is funded by the Bill and Melinda Gates Foundation and is part of a collaboration between the Kenyan Medical Research Institute (KEMRI) in Kenya; the US Centers for Disease Control and Prevention (CDC); the Liverpool School of Tropical Medicine (LSTM); the Ministry of Health, Kenya; the Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso; the Ministry of Health in Burkina Faso, and the London School of Hygiene and Tropical Medicine (LSHTM). LSTM and LSHTM will act as sponsors for the studies in Kenya and Burkina Faso, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Permuted block randomization
| Arm | Type | Receives |
|---|---|---|
| Artemether-lumefantrine | Active comparator | Drug: Artemether-lumefantrine (AL)Artemether-lumefantrine, standard 3-day antimalarial treatment regimen. |
| Pyronaridine-artesunate | Experimental | Drug: Pyronaridine-artesunate (PA)Pyronaridine-artesunate, standard 3-day antimalarial treatment regimen. |
Who may qualify
- Ages
- 6 months to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Laboratory confirmed SARS-CoV-2 infection, with positive molecular test results within the past 72 hours*
- Aged >=6 months **
- Resident in the study area
- The participant or caretaker is willing and able to give informed consent or assent with parent/guardian informed consent for participation in the study
- Agrees not to self-medicate with chloroquine, hydroxychloroquine or other antimalarials with potential anti-SARS-CoV-2 properties
Key exclusion criteria (11 listed)
- Unwilling or unable to provide informed consent/assent
- The participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results
- Inability/unlikely to be in the study area for the duration of the 28-day follow-up period
- Pregnant or lactating women
- Severe disease requiring parenteral treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrine (AL)Also: CoartemCurrent first line treatment of malaria. Dose: Bodyweight (kg) Dose (mg) of artemether + lumefantrine given twice daily for 3 days (total, six doses) 5 to < 15 20 + 120 15 to < 25 40 + 240 25 to < 35 60 + 360 >=35 80 + 480; Twice daily for 3 days (total, six doses) | Drug | Artemether-lumefantrine |
| Pyronaridine-artesunate (PA)Also: PyramaxAntimalarial; Dose: Body weight (kg) Dose (mg) of pyronaridine + aresunate given once daily for 3 days (total, three doses) 5 to < 8 60 + 20 8 to <15 120 + 40 15 to <20 180 + 60 20 to <24 kg 180 + 60 24 to <45 360 + 120 45 to <65 540 + 180 >=65 720 + 240; Once-daily for 3 days (total, three doses). | Drug | Pyronaridine-artesunate |
Primary outcome
Incidence of SARS-CoV-2 clearance
Time frame: by day 7
Defined as the proportion of participants with a negative nasal swab on Day 7 after the start of treatment
16 secondary outcomes
Median viral load of SARS-CoV-2
Time frame: by day 14
Cumulative incidence of SARS-CoV-2 clearance
Time frame: by days 14, 21 and 28
Time to clearance of nasal SARS-CoV-2
Time frame: by days 1, 3, 7, 14 and 28
Cumulative seroconversion rates (IgG, IgM, IgA)
Time frame: by days 7, 14, 21 and 28
IgG, IgM, IgA antibody titres against SARS-CoV-2
Time frame: by days 7, 14, 21 and 28
IL-6, IL-7, IL-10, TNF-alpha and Interferon-Gamma
Time frame: by days 3, 7, 14 and 28
CRP and angiotensin-2, angiopoietin-1 and angiopoietin-2
Time frame: by days 3, 7, 14 and 28
Genomic responses to SARS-CoV-2 infection
Time frame: by day 28
Cellular immune responses to SARS-CoV-2 infection
Time frame: by day 28
The clinical and parasitological antimalarial treatment response
Time frame: by day 42
COVID-19 disease severity
Time frame: by day 28
COVID-19 disease duration
Time frame: by day 28
COVID-19 fever duration
Time frame: by day 28
COVID-19 respiratory symptoms duration
Time frame: by day 28
COVID-19 disease duration in days
Time frame: by day 28
Treatment-related adverse events, serious adverse events, and adverse events resulting in treatment discontinuation
Time frame: by day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 41552003Tangara B, Barsosio HC, Marlais T, Kabore JMT, Tiono AB, Otieno K, Wanjiku M, Achieng M, Onyango ED, Ondieki ED, Aura H, Odawo T, Allen DJ, Hannan L, Tetteh KK, Soulama I, Ouedraogo A, Serme SS, Soulama BI, Barry A, Badoum ES, Matthewman J, Brazal-Monzo H, Canizales J, Drabko A, Wu W, Kariuki S, Lesosky M, Sirima SB, Drakeley C, Ter Kuile FO. Artemether-lumefantrine versus pyronaridine-artesunate for the treatment of malaria in patients with mild to moderate COVID-19 in Kenya and Burkina Faso: a randomised open-label trial (MALCOV). EClinicalMedicine. 2026 Jan 3;91:103735. doi: 10.1016/j.eclinm.2025.103735. eCollection 2026 Jan.
- Individual participant dataSharing planned: Yes. We will encourage data sharing to ensure that the scientific potential of this study is maximized. The full anonymized research database will be made publicly available as soon as the full study findings have been published or based on any data requests that may occur during the study or analysis is still ongoing. For the databases, we will use a controlled access approach.
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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.
Kariuki Simon, PhD principal investigator
Kenya Medical Research Institute
Sirima Sodiomon, MD, PhD principal investigator
Groupe de Recherche Action en Sante
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artemether-lumefantrine (AL) and Pyronaridine-artesunate (PA) in people with Covid-19 and Malaria, run by Liverpool School of Tropical Medicine at 2 sites in 2 countries.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Kenya. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of SARS-CoV-2 clearance (time frame: by day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04695197, which also lists 1 linked publication.
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 23 Feb 2024.