Covid-19Phase 3TRASCOVNCT04409483
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
A Phase 3 study testing Lopinavir-Ritonavir Drug Combination in people with Covid-19, run by Epicentre.
Trial summary
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Lopinavir-Ritonavir Drug Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Dec 2020
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suspect, probable or confirmed case of COVID-19
- Men and women aged ≥12 years, including pregnant and breastfeeding women
- SpO2 ≥93% on room air
- Signature of informed consent form
Who cannot join
- Medical indication for hospitalization at the time of enrolment
- Severe chronic liver disease
- Known infection with HIV
- Known allergy or severe intolerance to lopinavir/ritonavir
- Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)
- Treatment with an antiviral medication in the 28 days prior to enrolment
- Dementia or other condition that interferes with active participation in data collection and obtaining informed consent
About this study
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.
Read the detailed description
After being informed about the study and potential risks, all patients who meet all eligibility criteria and who give written informed consent will be randomized to receive standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14 days). Participants will receive daily visits from study staff for 15 days and be followed for a total of 28 days.
- Conditions
- Covid-19
- Being tested
- Lopinavir-Ritonavir Drug Combination, Standard Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir-Ritonavir Drug CombinationDrug
400mg/100mg taken orally twice daily for 14 days.
Standard CareCombination product
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Standard care for COVID-19 according to the national guidelines of Niger Receives: Combination Product: Standard Care |
| Standard Care plus lopinavir/ritonavir | Experimental | Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir Receives: Drug: Lopinavir-Ritonavir Drug Combination; Combination Product: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization or death
Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
Measured: 15 days following randomization
Secondary outcomes (7)
All-cause mortality
Death due to any cause
Measured: 15 days following randomization
All-cause mortality
Death due to any cause
Measured: 28 days following randomization
Time to hospitalization
Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)
Measured: 28 days following randomization
Length of hospitalization
Total duration of hospitalization associated with desaturation (SpO2 ≤92%)
Measured: 28 days following randomization
Admission to intensive care
Proportion of participants admitted to an intensive care unit
Measured: 28 days following randomization
Adverse events
Proportion of participants having an adverse event
Measured: 28 days following randomization
Serious adverse events
Proportion of participants having a serious adverse event
Measured: 28 days following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: Epidemic dynamics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Université Abdou Moumouni, Centre de Recherche Médicale et Sanitaire, Ministry of Public Health, Republic of Niger
- Responsible party
- Sponsor
- Investigators
- Rebecca F Grais, Study director, EpicentreEric Adehossi, Principal investigator, Hôpital Général de Référence de Niamey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409483
- Sponsor's protocol ID
- Trascov
- Acronym
- TRASCOV
- Status last verified
- Feb 2021
- First submitted
- 28 May 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient data will be shared with local and international authorities.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
- ClinicalTrials.gov ID
- NCT04409483
- Acronym / sponsor ID
- TRASCOV / Trascov
- Conditions
- Covid-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Epidemic dynamics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Université Abdou Moumouni, Centre de Recherche Médicale et Sanitaire, Ministry of Public Health, Republic of Niger
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jun 2020 (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.
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.
Detailed description
After being informed about the study and potential risks, all patients who meet all eligibility criteria and who give written informed consent will be randomized to receive standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14 days). Participants will receive daily visits from study staff for 15 days and be followed for a total of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Combination Product: Standard CareStandard care for COVID-19 according to the national guidelines of Niger |
| Standard Care plus lopinavir/ritonavir | Experimental | Drug: Lopinavir-Ritonavir Drug Combination, Combination Product: Standard CareStandard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Suspect, probable or confirmed case of COVID-19
- Men and women aged ≥12 years, including pregnant and breastfeeding women
- SpO2 ≥93% on room air
- Signature of informed consent form
Key exclusion criteria (7 listed)
- Medical indication for hospitalization at the time of enrolment
- Severe chronic liver disease
- Known infection with HIV
- Known allergy or severe intolerance to lopinavir/ritonavir
- Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)
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 |
|---|---|---|
| Lopinavir-Ritonavir Drug Combination400mg/100mg taken orally twice daily for 14 days. | Drug | Standard Care plus lopinavir/ritonavir |
| Standard CareParacetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily | Combination product | Standard Care, Standard Care plus lopinavir/ritonavir |
Primary outcome
Hospitalization or death
Time frame: 15 days following randomization
Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
7 secondary outcomes
All-cause mortality
Time frame: 15 days following randomization
All-cause mortality
Time frame: 28 days following randomization
Time to hospitalization
Time frame: 28 days following randomization
Length of hospitalization
Time frame: 28 days following randomization
Admission to intensive care
Time frame: 28 days following randomization
Adverse events
Time frame: 28 days following randomization
Serious adverse events
Time frame: 28 days following randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Yes. De-identified patient data will be shared with local and international authorities.
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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.
Rebecca F Grais study director
Epicentre
Eric Adehossi principal investigator
Hôpital Général de Référence de Niamey
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lopinavir-Ritonavir Drug Combination in people with Covid-19, run by Epicentre.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Hospitalization or death (time frame: 15 days following randomization). 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 10 Feb 2021.