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Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger (TRASCOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409483
Recruitment Status : Withdrawn (Epidemic dynamics)
First Posted : June 1, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
Université Abdou Moumouni
Centre de Recherche Médicale et Sanitaire
Ministry of Public Health, Republic of Niger
Information provided by (Responsible Party):
Epicentre

Brief 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.

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Lopinavir-Ritonavir Drug Combination Combination Product: Standard Care Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Care
Standard care for COVID-19 according to the national guidelines of Niger
Combination Product: Standard Care
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily

Experimental: Standard Care plus lopinavir/ritonavir
Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
Drug: Lopinavir-Ritonavir Drug Combination
400mg/100mg taken orally twice daily for 14 days.

Combination Product: Standard Care
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily




Primary Outcome Measures :
  1. Hospitalization or death [ Time Frame: 15 days following randomization ]
    Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 15 days following randomization ]
    Death due to any cause

  2. All-cause mortality [ Time Frame: 28 days following randomization ]
    Death due to any cause

  3. Time to hospitalization [ Time Frame: 28 days following randomization ]
    Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)

  4. Length of hospitalization [ Time Frame: 28 days following randomization ]
    Total duration of hospitalization associated with desaturation (SpO2 ≤92%)

  5. Admission to intensive care [ Time Frame: 28 days following randomization ]
    Proportion of participants admitted to an intensive care unit

  6. Adverse events [ Time Frame: 28 days following randomization ]
    Proportion of participants having an adverse event

  7. Serious adverse events [ Time Frame: 28 days following randomization ]
    Proportion of participants having a serious adverse event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409483


Sponsors and Collaborators
Epicentre
Université Abdou Moumouni
Centre de Recherche Médicale et Sanitaire
Ministry of Public Health, Republic of Niger
Investigators
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Study Director: Rebecca F Grais Epicentre
Principal Investigator: Eric Adehossi Hôpital Général de Référence de Niamey
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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT04409483    
Other Study ID Numbers: Trascov
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified patient data will be shared with local and international authorities.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become fully accessible after primary publication of results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors