Clinical Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19

NCT ID: NCT04712357

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2023-01-31

Brief Summary

Clinical, control, double-blind, randomized trial with tenofovir disoproxyl fumarate and emtricitabine for Covid-19

Detailed Description

Several therapeutic agents have been evaluated for the treatment of Covid-19, and only one using an antiviral drug called remdesivir administered intravenously has shown efficacy to reduce the duration of the disease in 26.7% in critically ill patients. This proposal has as its primary objective (a) Determine the effect of TDF and TDF + FTC on the duration of Covid-19 evaluated in the 14th. day of follow-up at the outpatient clinic in the hospital, duration of the disease observing clinical signs and symptoms, as well as evaluating the RT-PCR viral load tests on the 1st, 7th, 14th. and 28th. days of the study protocol. In addition, the proposal assesses several secondary objectives: (b) Assess the action of TDF and TDF + FTC on the immune response using the rapid ELISA test (IgM / IgG) to be performed on the 7th. and 28th. days of monitoring the experimental protocol; (c) Determine the effect of clinical interventions with the drugs TDF and TDF + FTC in the short and medium term on the viral load of SARS-CoV-2; and (d) Assess the effect of TDF and TDF + FTC on inflammation biomarkers cytokines and chemokines (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-α, MCP-1 , IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I, CRP and procalcitonin) in the blood of patients collected in the 1st, 14th. and 28th. study days. The study will be a prospective, double-blind, placebo control and randomized clinical trial of a total of 219 patients with mild to moderate disease, aged 18 years or over, with clinical signs and symptoms of Covid-19 and certified after the RT-PCR test for the detection of SARS-CoV-2 viral load. The study will be carried out at the outpatient clinic of Hospital São José, Fortaleza, CE. The random groups will be: (1) Group - Placebo control (Vitamin C - 500mg / day, for 10 days); (2) Group - tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days); and (3) Group - TDF + emtricitabine (FTC; 200 mg / day, for 10 days). The study aims to evaluate the efficacy of tenofovir alone or combined with emtricitabine in the duration of mild to moderate Covid-19 cases. The study will also assess the effect of drugs on viral load and immune-inflammatory response. In this sense, the study has the perspective of minimizing the evolution of the disease to severe cases, thus relieving the collapse of the health system and minimizing the social, economic and health disorders of the pandemic by SARS-CoV-2.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo (Vitamin C)

Control placebo (Vitamin C - 500mg / day, for 10 days)

Group Type: PLACEBO_COMPARATOR

Vitamin C 500 MG Oral Tablet

Intervention Type: DRUG

Vitamin C 500 MG per day for 10 days

Tenofovir disoproxyl fumarate (TDF)

Tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days)

Group Type: ACTIVE_COMPARATOR

Tenofovir disoproxyl fumarate 300 MG Oral Tablet

Intervention Type: DRUG

Tenofovir disoproxyl fumarate 300 MG per day for 10 days

TDF + FTC

Tenofovir disoproxyl fumarate (TDF; 300 mg / day, for 10 days) plus emtricitabine (FTC; 200 mg / day, for 10 days)

Group Type: ACTIVE_COMPARATOR

Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet

Intervention Type: DRUG

Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG per day for 10 days

Interventions

Vitamin C 500 MG Oral Tablet

Vitamin C 500 MG per day for 10 days

Intervention Type: DRUG

Tenofovir disoproxyl fumarate 300 MG Oral Tablet

Tenofovir disoproxyl fumarate 300 MG per day for 10 days

Intervention Type: DRUG

Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet

Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG per day for 10 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is > 18 years old
• Patient diagnosed with COVID-19

Exclusion Criteria

• Patient is already receiving some of the study drugs
• There is a hospitalization plan in the next 24h
• Some study treatment is contraindicated
• Patient has HIV infection
• Patient has VHB infection
• Patient lives in another city or state
• Female patient, pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

São José Hospital for Infectious Diseases - HSJ

UNKNOWN

Sponsor Role: collaborator

Central Laboratory of Public Health of Ceará - Lacen-CE

UNKNOWN

Sponsor Role: collaborator

Universidade Federal do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Aldo Ângelo Moreira Lima

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Núcleo de Biomedicina - NUBIMED

Fortaleza, Ceará, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Aldo AM Lima, Ph.D.

Role: CONTACT

alima@ufc.br

5585987042833

Alexandre H Binda, Ph.D.

Role: CONTACT

ahavt@ufc.br

5585987565695

Facility Contacts

Aldo A M Lima, PI

Role: primary

alima@ufc.br

+5585987042833

Alexandre Havt Bindá, Co-PI

Role: backup

ahavt@ufc.br

+5585987565695

Other Identifiers

CAAE: 34182620.0.0000.5045

Identifier Type: -

Identifier Source: org_study_id