Covid19COVISTANCT04885543
COVID-19 STAndard of Care in Sub-Saharan Africa
An observational study of Covid19, run by Alliance for International Medical Action at 3 sites in 2 countries.
Trial summary
This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 2,495 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2020to 1 Mar 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People hospitalized with symptomatic of COVID-19 and a positive RT-PCR SARS-CoV-2 test
Who may be able to join
- SARS-CoV-2 positive at RT-PCR
Who cannot join
- Asymptomatic patients
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Burkina Faso2 sites
Chu Tengandogo
Ouagadougou, BP104
Clinique Princesse Sarah
Ouagadougou, BP51145
About this study
Official title: Observational Study of the Clinico-biological Evolution and the Standard of Care Offered to Symptomatic Covid-19 Patients in Sub-Saharan Africa
This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In hospital mortality
Measured: During hospitalization, with an average of 11 days
Secondary outcomes (1)
Clinical worsening
Combination of an SpO2 <94% at least once during follow-up (including at baseline), use of oxygen therapy at any time during follow-up, or death
Measured: Hospitalization, with an average of 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Malvy, Pr, Principal investigator, CHU Bordeaux, INSERM 1219
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885543
- Sponsor's protocol ID
- ALIMA02
- Acronym
- COVISTA
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Clinico-biological Evolution and the Standard of Care Offered to Symptomatic Covid-19 Patients in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT04885543
- Acronym / sponsor ID
- COVISTA / ALIMA02
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,495 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 May 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.
This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People hospitalized with symptomatic of COVID-19 and a positive RT-PCR SARS-CoV-2 test
Key inclusion criteria (1 listed)
- SARS-CoV-2 positive at RT-PCR
Key exclusion criteria (1 listed)
- Asymptomatic patients
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
Mortality
Time frame: During hospitalization, with an average of 11 days
In hospital mortality
1 secondary outcome
Clinical worsening
Time frame: Hospitalization, with an average of 11 days
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 13 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Denis Malvy, Pr principal investigator
CHU Bordeaux, INSERM 1219
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Alliance for International Medical Action at 3 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 1 inclusion and 1 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Burkina Faso, Guinea. 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?
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?
Mortality (time frame: During hospitalization, with an average of 11 days). 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 13 May 2021.