Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19) (CCOVID-19)
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|ClinicalTrials.gov Identifier: NCT04535869|
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : February 24, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Sofosbuvir 400 MG plus Daclatasvir 200mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19)|
|Actual Study Start Date :||December 28, 2020|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||September 3, 2021|
No Intervention: A)standard therapy group
No intervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol
Active Comparator: B)Standard Therapy group plus Ant-HCV drugs
Intervention COVID- 19 patients who received a standard therapy group according to the ministry of health protocol plus sofosbuvir 400 mg and Daclatasvir 200mg
Drug: Sofosbuvir 400 MG plus Daclatasvir 200mg
This group which receive sofosbuvir and daclatasvir for 14 days plus standard therapy
Other Name: Direct antiviarl agents
- rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment [ Time Frame: for every case must be done after 2 weeks from the start of treatment. ]All PCR for COVID must be negative
- resolution of pneumonia BY high resolution Computed tomography [ Time Frame: Computed tomography must be done after 2 weeks to detect resolution of pneumonia ]clinical status as assessed by earlier resolution of pneumonia in the intervention arm when compared to the control group
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): NCT04535869
|Contact: Mahmoud El-Bendary, M.Dfirstname.lastname@example.org|
|Contact: Hatem Elalfy, M.Demail@example.com|
|Mansoura Faculty of Medicine||Recruiting|
|Mansoura, Dakahlyia, Egypt, 35516|
|Contact: Mahmoud El-Bendary, M.D 00201002592205 firstname.lastname@example.org|