Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19)
CCOVID-19
1 other identifier
interventional
50
1 country
1
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 our study is to assess the safety and efficacy of of the addition of HCV treatment to the standard regimen for the treatment of patients according to MOHP protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 covid19
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2021
CompletedFebruary 24, 2021
August 1, 2020
3 months
August 28, 2020
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment
All PCR for COVID must be negative
for every case must be done after 2 weeks from the start of treatment.
Secondary Outcomes (1)
resolution of pneumonia BY high resolution Computed tomography
Computed tomography must be done after 2 weeks to detect resolution of pneumonia
Study Arms (2)
A)standard therapy group
NO INTERVENTIONNo intervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol
B)Standard Therapy group plus Ant-HCV drugs
ACTIVE COMPARATORIntervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol plus sofosbuvir 400 mg and Daclatasvir 200mg
Interventions
This group which receive sofosbuvir and daclatasvir for 14 days plus standard therapy
Eligibility Criteria
You may qualify if:
- All cases positive for COVID-19
- Male and non-pregnant female patients,
- years of age or older,
- All moderate and severe caseswith pneuomnia.
You may not qualify if:
- Known allergy or hypersensitivity to the used medications
- Known severe liver disease
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura Faculty of Medicine
Al Mansurah, Dakahlyia, 35516, Egypt
Related Publications (5)
Hallin RW. Femoropopliteal versus femorotibial bypass grafting for lower extremity revascularization. Am Surg. 1976 Jul;42(7):522-6.
PMID: 937862BACKGROUNDDepo-Provera may be linked to uterine cancer, preliminary data imply. Fam Plann Perspect. 1979 Jan-Feb;11(1):47. No abstract available.
PMID: 105932BACKGROUNDO'Brien PJ, Hawco FJ. Hydroxyl-radical formation during prostaglandin formation catalysed by prostaglandin cyclo-oxygenase [proceedings]. Biochem Soc Trans. 1978;6(6):1169-71. doi: 10.1042/bst0061169. No abstract available.
PMID: 105949BACKGROUNDKirkegaard C, Faber J, Hummer L, Rogowski P. Increased levels of TRH in cerebrospinal fluid from patients with endogenous depression. Psychoneuroendocrinology. 1979 Jul;4(3):227-35. doi: 10.1016/0306-4530(79)90006-4. No abstract available.
PMID: 117477BACKGROUNDPhelan AL, Katz R, Gostin LO. The Novel Coronavirus Originating in Wuhan, China: Challenges for Global Health Governance. JAMA. 2020 Feb 25;323(8):709-710. doi: 10.1001/jama.2020.1097. No abstract available.
PMID: 31999307RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Tropical Medicine and Hepatogastroenterology
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 2, 2020
Study Start
December 28, 2020
Primary Completion
April 1, 2021
Study Completion
September 3, 2021
Last Updated
February 24, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share