Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19
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|ClinicalTrials.gov Identifier: NCT04498936|
Recruitment Status : Completed
First Posted : August 5, 2020
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID||Drug: Sofosbuvir and Ledipasvir Drug: Nitazoxanide||Phase 4|
This study is an open-label, randomized, controlled trial. A total of 240 patients who are recruited in 2 quarantine hospitals (15th of May hospital, Cairo, and Al Rajhi hospital, Assiut), will be randomly assigned in a 1:1:1 ratio (80 patient in each treatment arm), to receive either the fixed combination of Sofosbuvir/Ledipasvir (400 mg and 90 mg, orally) once daily for 14 days, plus the standard care treatment regimen (SCT) for COVID-19 patients according to the Egyptian Ministry of Health (MOH) protocol (Group 1), or nitazoxanide (500 mg, orally) four times per day for 14 days, plus STC (Group 2), or SCT alone (Group 3). All treatment groups will be followed up by laboratory investigations and PCR for SARS-CoV-2 virus at the time of enrollment, days 5, 8, 11, and 14. Supportive care comprised, as necessary, supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation (ECMO). To ensure a balanced distribution of case severities in all study groups, randomization will be stratified based on the case severity index issued by WHO (https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf).
Written informed consent will be obtained from all patients or the patient's legal representative if the patient is too unwell to provide consent. The trial will be conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Conference on Harmonisation. The authors are responsible for designing the trial and for compiling and analyzing the data. The authors vouch for data completeness and accuracy and adherence to the trial protocol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Adding Sofosbuvir/Ledipasvir Combination, or Nitazoxanide to the Standard of Care in Treatment of COVID-19: A Randomized Controlled Trial|
|Actual Study Start Date :||July 15, 2020|
|Actual Primary Completion Date :||October 30, 2020|
|Actual Study Completion Date :||October 30, 2020|
This group will receive a fixed combination of Sofosbuvir/Ledipasvir (400 mg and 90 mg, orally) once daily for 14 days, plus the standard care treatment regimen (SCT) for COVID-19 patients according to the Egyptian Ministry of Health (MOH) protocol.
Drug: Sofosbuvir and Ledipasvir
Evaluate the efficacy of Sofosbuvir/Ledipasvir in treatment of COVID-19
Other Name: Treatment
This group will receive nitazoxanide (500 mg, orally) four times per day for 14 days, plus the standard care treatment regimen (SCT) for COVID-19 patients according to the Egyptian Ministry of Health (MOH) protocol.
Evaluate the efficacy of Nitazoxanide in treatment of COVID-19
Other Name: Treatment
No Intervention: Standard care treatment
This group will receive only the standard care treatment regimen (SCT) for COVID-19 patients according to the Egyptian Ministry of Health (MOH) protocol.
- Change of PCR from positive to negative [ Time Frame: 2 weeks ]The PCR will be done at time of recruitment, day 5, 8, 11, and 14. The time taken to have negative will be measured in each group.
- Clinical improvement [ Time Frame: 2 weeks ]Clinical improvement will be measured by detection of downgrading of cases severity according to the World Health Organization case severity classification.
- Adverse events [ Time Frame: 2 weeks ]All patients will be asked about any possible adverse effects that they may suffer from taken drugs during their follow up. Any mentioned side effect will be reported. Drug discontinuation and it cause will be also reported if it happened.
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): NCT04498936
|15th May Hospital|
|Helwan, Cairo, Egypt|
|Assiut University Hospital|
|Assiut, Egypt, 71515|
|Principal Investigator:||Mohammed A Medhat, PhD||Assiut University|
|Study Chair:||Mohamed El Kassas, PhD||Helwan University|
|Principal Investigator:||Haidi K Ramadan, PhD||Assiut University|