Efficacy and Safety of Anti HCV Drugs in the Treatment of COVID-19

NCT04443725 | Unknown Phase 2 DMC

• 1 other identifier: CUKA-003
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

COVID 19 which started from a zoonotic transmission related to crowded markets was confirmed to have a high potential for transmission to close contacts on 20 January 2020 by the National Health Commission of China and it was announced as a pandemic by the WHO on 11 March 2020. There is currently no clinically proven specific antiviral agent available for SARS-CoV-2 infection. Supportive treatment, including oxygen therapy, conservation fluid management, and broad-spectrum antibiotics to cover secondary bacterial infection, remains the most important management strategy. Interestingly, sofosbuvir has recently been proposed as an antiviral for the SARS-CoV-2 based on the similarity between the replication mechanisms of the HCV and the coronaviruses. Aim of the study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients who are candidates to receive Hydroxy Chloroquine according to Egyptian MOHP protocol

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Virological cure

  virological cure using the triple therapy as compared to mono hydroxychloroquine treatment..

  28 days

Study Arms (2)

Hydroxychloroquine plus Sofosbuvir/Daclatasvir

EXPERIMENTAL

Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days, Sofosbuvir 400 mg once daily for 14 days and daclatasvir 90 mg for 14 days

Drug: Hydroxychloroquine , Sofosbuvir, daclatasvir

Standard of care

ACTIVE COMPARATOR

Hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days

Drug: Standard of care treatment

Interventions

Hydroxychloroquine , Sofosbuvir, daclatasvir DRUG

Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days (dose reductions for weight \< 45 kg or GFR (glomerular filtration rate) \<50ml/min) alone; as provided by the MOHP protocol), Sofosbuvir 400 mg once daily for 14 days and daclatasvir 90 mg for 14 days.

Hydroxychloroquine plus Sofosbuvir/Daclatasvir

Standard of care treatment DRUG

Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days (dose reductions for weight \< 45 kg or GFR (glomerular filtration rate) \<50ml/min) alone; as provided by the MOHP protocol),

Standard of care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• positive reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay for SARS- CoV-2 in a respiratory tract sample

You may not qualify if:

• ● Known allergy or hypersensitivity to the used medications
• Known severe liver disease (e.g., cirrhosis, with an alanine aminotransferase level \>5× the upper limit of the normal range or an aspartate aminotransferase level \>5× the upper limit of the normal range)
• Use of medications that are contraindicated with the trial medications and that could not be replaced or stopped during the trial period
• Pregnancy or breast-feeding or known active HCV infection, because of concerns about the development of resistance
• History of bone marrow transplant
• Known G6PD deficiency
• Chronic hemodialysis or Glomerular Filtration Rate \< 20ml/min
• Psoriasis
• Porphyria
• Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
• Known history of long QT syndrome
• Current known QTc\>500 msec
• Pregnant or nursing
• Weight \< 35kg
• Seizure disorder

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine; Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endemic Medicine

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: July 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06