Covid19Phase 2/3COVERAGE-ANCT04920838
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
A Phase 2/3 study testing Nitazoxanide and Ciclésonide, Telmisartan 20Mg Oral Tablet and Paracetamol in people with Covid19 and Covid19 Drug Treatment, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.
Trial summary
Coverage Africa is a nested study in the large Anticov platform trial that aims to generate data on new early treatment strategies for mild/moderate COVID-19 patients in resource-limited-settings to reduce the number progressing to severe forms requiring hospitalization, thereby relieving the burden on health care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Covid19 Drug Treatment, Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- Nitazoxanide and Ciclésonide, Telmisartan 20Mg Oral Tablet and Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Apr 2021to Aug 2023
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years of age at the time of screening or >= 40 years and presenting at least one comorbidity : high blood pressure; a known obesity and/ or a known and treated diabete.
- SARS-CoV-2 infection confirmed by molecular biology (RT-PCR on a nasopharyngeal or oropharyngeal swab) or by antigen test validated in the country according to national guidelines
- A viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) >=94%.
- Mild Covid-19 symptoms with an onset < 7 days before inclusion.
- Signed written consent from the patient or his/her representative.
- No need an oxygen therapy according to international guidelines (WHO Progression Scale, grade 2 to 4)
Show all 9Show fewer
- Accepting and having the ability to be reached by telephone throughout the study.
- Having designated a contact person who can be contacted in case of emergency.
- Accepted to be reached by phone along throughout the study
Who cannot join
- Blood oxygen saturation level (SpO2) < 94%.
- Known hypersensitivity to investigational products
- Chronic treatment with inhaled corticosteroids (up to 30 days)
- Known history of renal or hepatic failure
- Abnormal physical examination findings:
- respiratory rate < 25 per minute;
Show all 15Show fewer
- Clinical hypotension with associated signs justifying hospital care
- Feeling unwell for more than 7 days prior to screening.
- End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
- For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use.
- Patients with known suicidal thoughts, severe psychiatric disorders or major depression that is uncontrolled or controlled by one of the prohibited drugs
- Known history of long QT syndrome or severe ventricular cardiac arrhythmia (ventricular tachycardia, patients with recovered ventricular fibrillation)
- Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber.
- Any other reason that makes it impossible to monitor the patient during the study.
- Enrolled in other clinical trials with unregistered drugs or with registered drugs that may interact with any of the study IPs or are contraindicated as concomitant therapy within the last 3 months prior to screening
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Burkina Faso1 site, 1 recruiting
- Recruiting
Centre Muraz/INSP
Bobo-Dioulasso
Armel Poda, Pr., 65314949 ext. +226, armelpoda@yahoo.fr
Apoline Sondo, Pr, 70077198 ext. +226, sondoapoline@yahoo.fr
Guinea1 site
- Suspended
Centre de traitement des maladies à tendance épidémique de Gbessia
Conakry
About this study
Official title: Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan Africa (COVERAGE-Africa)
Coverage Africa is a nested study in the large Anticov platform trial that aims to generate data on new early treatment strategies for mild/moderate COVID-19 patients in resource-limited-settings to reduce the number progressing to severe forms requiring hospitalization, thereby relieving the burden on health care systems and contributing to "flattening the curve" in contexts where none pharmaceutical intervention such as quarantine are difficult to implement in large urban settings. Treating early when the virus is still present might also limit transmission. Coverage Africa will be conducted in Guinea and Burkina Faso.
The main objective is to conduct an open-label, multicenter, randomized, adaptive platform trial to test the safety and efficacy of several marketed products, including antiviral therapies versus control in mild/moderate of coronavirus disease 2019 (Covid-19) in resource-limited-settings.
Read more
The study aims to recruit 600 patients in both countries, one site in Guinea and two sites in Burkina Faso.
The current assessed treatments are now the association of Fluoxétine/Budésonide compared with a control arm: paracetamol.
The adaptive design trial will allow for the removal of drugs, or the addition of new study arms when new data becomes available. Data on the primary efficacy parameters and safety will be integrated with the primary endpoint based on an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment, including death for any reason.
Study will run until August 2022. However, with the proposed adaptive design, the study could also be interrupted for success earlier than planned with the identification of a treatment that significantly reduces hospitalization rate as evidence by results from the primary endpoint.
- Conditions
- Covid19, Covid19 Drug Treatment, Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2 Infection
- Being tested
- Nitazoxanide and Ciclésonide, Telmisartan 20Mg Oral Tablet, Paracetamol, Fluoxétine and Budésonide
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitazoxanide and CiclésonideDrug
Inhaled Ciclésonide: 320 mcg BID per day and Oral Nitazoxanide:2000 mg tablets daily (divided into two daily intakes of two tablets of nitazoxanide 500 mg) during 14 days.
Telmisartan 20Mg Oral TabletDrug
20 mg tablet daily
ParacetamolDrug
Tablets containing 500 mg of paracetamol. One to two tablets every 4-6 hours as required, to a maximum of 6 tablets (3 grams) daily in divided doses.
Duration of treatment: up to 14 days
Fluoxétine and BudésonideDrug
Inhaled Budésonide: 400mcg BID per day and oral Fluoxétine : 80mg tablets daily (divided into two daily intakes of two tablets of Fluoxétine 40 mg) during 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Patients in this arm will receive paracetamol during 14 days Receives: Drug: Paracetamol |
| Nitazoxanide and Ciclésonide | Experimental | Patients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days Receives: Drug: Nitazoxanide and Ciclésonide |
| Telmisartan | Experimental | Patients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days Receives: Drug: Telmisartan 20Mg Oral Tablet |
| Fluoxétine and Budésonide | Experimental | Patients in this arm will receive the combination of Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2*400 mcg) during 7 days Receives: Drug: Fluoxétine and Budésonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 ≤ 93% within 14 days
Percentage of participant presenting an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment.
Measured: From inclusion (day 0) to day 14.
Death within 14 days
Percentage of participant dead within 14 days after randomization to treatment, including death for any reason.
Measured: From inclusion (day 0) to day 14.
Secondary outcomes (3)
Death within 28 days
Percentage of participant dead within 28 days after randomization to treatment, including death for any reason.
Measured: From inclusion (day 0) to day 28.
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
Measured: From inclusion (day 0) to day 14.
Number of hospitalizations due to severe progression
Hospitalisation due to aggravation of COVID-19, including hospitalisation's reason as described below
- Request of mechanical ventilation and/or Intensive Care Unit (ICU)
- Non-ICU hospitalisation, requiring supplemental oxygen
- Non-ICU hospitalisation, not requiring supplemental oxygen
Measured: From inclusion (day 0) to day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start12 Apr 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
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 Covid19Studies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentre, multiple country, randomised, open-label, adaptive, platform clinical study aiming to determine the efficacy and safety of various treatment regimens for prevention of the need for hospitalisation for specialised care due to severe progression of COVID-19. The study is designed with the ability to incorporate the adding or dropping of treatment arms and that will include similar inclusion and non-inclusion criteria, the same primary and secondary endpoints, common data entry procedures, a shared database and a single statistical methodology for analysis of the primary endpoint.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PACCI Program, Alliance for International Medical Action, Centre Muraz, Barcelona Institute for Global Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920838
- Sponsor's protocol ID
- ANRS COV33 COVERAGE-Africa
- Acronym
- COVERAGE-A
- Status last verified
- Jul 2022
- First submitted
- 4 May 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Doucet MH, Songbono CT, Plazy M, Martin C, Fritzell C, Sow MS, Traore FA, Jaspard M, Poda A, Malvy D, Marcy O, Delamou A, Orne-Gliemann J. Perceptions of COVID-19 among communities of Conakry (Guinea): a qualitative study exploring the context of the ANRS COV33 Coverage-Africa therapeutic trial. BMJ Open. 2022 Dec 27;12(12):e061715. doi: 10.1136/bmjopen-2022-061715.
PubMed 36574985
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan Africa (COVERAGE-Africa)
- ClinicalTrials.gov ID
- NCT04920838
- Acronym / sponsor ID
- COVERAGE-A / ANRS COV33 COVERAGE-Africa
- Conditions
- Covid19, Covid19 Drug Treatment, Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV2 Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France, PACCI Program, Alliance for International Medical Action, Centre Muraz, Barcelona Institute for Global Health
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 10 Jun 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.
Coverage Africa is a nested study in the large Anticov platform trial that aims to generate data on new early treatment strategies for mild/moderate COVID-19 patients in resource-limited-settings to reduce the number progressing to severe forms requiring hospitalization, thereby relieving the burden on health care systems and contributing to "flattening the curve" in contexts where none pharmaceutical intervention such as quarantine are difficult to implement in large urban settings. Treating early when the virus is still present might also limit transmission. Coverage Africa will be conducted in Guinea and Burkina Faso.
The main objective is to conduct an open-label, multicenter, randomized, adaptive platform trial to test the safety and efficacy of several marketed products, including antiviral therapies versus control in mild/moderate of coronavirus disease 2019 (Covid-19) in resource-limited-settings.
The study aims to recruit 600 patients in both countries, one site in Guinea and two sites in Burkina Faso.
The current assessed treatments are now the association of Fluoxétine/Budésonide compared with a control arm: paracetamol.
The adaptive design trial will allow for the removal of drugs, or the addition of new study arms when new data becomes available. Data on the primary efficacy parameters and safety will be integrated with the primary endpoint based on an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment, including death for any reason.
Study will run until August 2022. However, with the proposed adaptive design, the study could also be interrupted for success earlier than planned with the identification of a treatment that significantly reduces hospitalization rate as evidence by results from the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a multicentre, multiple country, randomised, open-label, adaptive, platform clinical study aiming to determine the efficacy and safety of various treatment regimens for prevention of the need for hospitalisation for specialised care due to severe progression of COVID-19. The study is designed with the ability to incorporate the adding or dropping of treatment arms and that will include similar inclusion and non-inclusion criteria, the same primary and secondary endpoints, common data entry procedures, a shared database and a single statistical methodology for analysis of the primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: ParacetamolPatients in this arm will receive paracetamol during 14 days |
| Nitazoxanide and Ciclésonide | Experimental | Drug: Nitazoxanide and CiclésonidePatients in this arm will receive the combination of ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg) during 14 days |
| Telmisartan | Experimental | Drug: Telmisartan 20Mg Oral TabletPatients in this arm will receive telmisartan (Micardis® 20 mg) during 10 days |
| Fluoxétine and Budésonide | Experimental | Drug: Fluoxétine and BudésonidePatients in this arm will receive the combination of Fluoxétine (Fluoxétine Arrow® 40 mg ) / Budésonide (Budecort® 2*400 mcg) during 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 18 years of age at the time of screening or >= 40 years and presenting at least one comorbidity : high blood pressure; a known obesity and/ or a known and treated diabete.
- SARS-CoV-2 infection confirmed by molecular biology (RT-PCR on a nasopharyngeal or oropharyngeal swab) or by antigen test validated in the country according to national guidelines
- A viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) >=94%.
- Mild Covid-19 symptoms with an onset < 7 days before inclusion.
- Signed written consent from the patient or his/her representative.
Key exclusion criteria (15 listed)
- Blood oxygen saturation level (SpO2) < 94%.
- Known hypersensitivity to investigational products
- Chronic treatment with inhaled corticosteroids (up to 30 days)
- Known history of renal or hepatic failure
- Abnormal physical examination findings:
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 |
|---|---|---|
| Nitazoxanide and CiclésonideInhaled Ciclésonide: 320 mcg BID per day and Oral Nitazoxanide:2000 mg tablets daily (divided into two daily intakes of two tablets of nitazoxanide 500 mg) during 14 days. | Drug | Nitazoxanide and Ciclésonide |
| Telmisartan 20Mg Oral Tablet20 mg tablet daily | Drug | Telmisartan |
| ParacetamolTablets containing 500 mg of paracetamol. One to two tablets every 4-6 hours as required, to a maximum of 6 tablets (3 grams) daily in divided doses. Duration of treatment: up to 14 days | Drug | Paracetamol |
| Fluoxétine and BudésonideInhaled Budésonide: 400mcg BID per day and oral Fluoxétine : 80mg tablets daily (divided into two daily intakes of two tablets of Fluoxétine 40 mg) during 7 days. | Drug | Fluoxétine and Budésonide |
Primary outcome
SpO2 ≤ 93% within 14 days
Time frame: From inclusion (day 0) to day 14.
Percentage of participant presenting an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment.
Death within 14 days
Time frame: From inclusion (day 0) to day 14.
Percentage of participant dead within 14 days after randomization to treatment, including death for any reason.
3 secondary outcomes
Death within 28 days
Time frame: From inclusion (day 0) to day 28.
Occurence of at least one grade 3 or 4 clinical or biological adverse event within 14 days
Time frame: From inclusion (day 0) to day 14.
Number of hospitalizations due to severe progression
Time frame: From inclusion (day 0) to day 28.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 36574985Doucet MH, Songbono CT, Plazy M, Martin C, Fritzell C, Sow MS, Traore FA, Jaspard M, Poda A, Malvy D, Marcy O, Delamou A, Orne-Gliemann J. Perceptions of COVID-19 among communities of Conakry (Guinea): a qualitative study exploring the context of the ANRS COV33 Coverage-Africa therapeutic trial. BMJ Open. 2022 Dec 27;12(12):e061715. doi: 10.1136/bmjopen-2022-061715.
- Individual participant dataSharing planned: Yes
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nitazoxanide and Ciclésonide, Telmisartan 20Mg Oral Tablet and Paracetamol in people with Covid19 and Covid19 Drug Treatment, run by ANRS, Emerging Infectious Diseases 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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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, 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Marcy, Dr (+33 557 57 47 23, olivier.marcy@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 ≤ 93% within 14 days (time frame: From inclusion (day 0) to day 14.). The study lists 2 primary outcomes in all. 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 NCT04920838, 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 31 Jan 2023.