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

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid-19
• Intervention / Treatment: Combination product: Standard Care; Drug: Lopinavir-Ritonavir Drug Combination

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 Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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	Combination product: Standard Care; Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily; Drug: Lopinavir-Ritonavir Drug Combination; 400mg/100mg taken orally twice daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization or death	Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause	15 days following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Death due to any cause	15 days following randomization
All-cause mortality	Death due to any cause	28 days following randomization
Time to hospitalization	Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)	28 days following randomization
Length of hospitalization	Total duration of hospitalization associated with desaturation (SpO2 ≤92%)	28 days following randomization
Admission to intensive care	Proportion of participants admitted to an intensive care unit	28 days following randomization
Adverse events	Proportion of participants having an adverse event	28 days following randomization
Serious adverse events	Proportion of participants having a serious adverse event	28 days following randomization

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Université Abdou Moumouni; Centre de Recherche Médicale et Sanitaire; Ministry of Public Health, Republic of Niger
• Investigators: Study Director: Rebecca F Grais, Epicentre; Principal Investigator: Eric Adehossi, Hôpital Général de Référence de Niamey

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir
• Other Study ID Numbers: Trascov

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified patient data will be shared with local and international authorities.
• IPD Sharing Time Frame: Data will become fully accessible after primary publication of results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No