Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19

NCT04498936 | Completed Phase 4

• 1 other identifier: COVID-19 treatment
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The efficacy of treating COVID-19 infection by using Sofosbuvir/Ledipasvir and Nitazoxanide will be examined. Included patients will be into 3 groups. The 1st group will receive Sofosbuvir/Ledipasvir plus the standard care treatment (SCT). The 2nd group will take Nitazoxanide and SCT, while the 3rd group will receive only SCT. Then the clinical improvement and the rate of PCR change from positive to negative will be evaluated in each group.

Conditions

COVID

Outcome Measures

Primary Outcomes (2)

• Change of PCR from positive to negative

  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.

  2 weeks

• Clinical improvement

  Clinical improvement will be measured by detection of downgrading of cases severity according to the World Health Organization case severity classification.

  2 weeks

Secondary Outcomes (1)

• Adverse events

  2 weeks

Study Arms (3)

Sofosbuvir/Ledipasvir

EXPERIMENTAL

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

Nitazoxanide

EXPERIMENTAL

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.

Drug: Nitazoxanide

Standard care treatment

NO INTERVENTION

This group will receive only the standard care treatment regimen (SCT) for COVID-19 patients according to the Egyptian Ministry of Health (MOH) protocol.

Interventions

Sofosbuvir and Ledipasvir DRUG

Evaluate the efficacy of Sofosbuvir/Ledipasvir in treatment of COVID-19

Also known as: Treatment

Sofosbuvir/Ledipasvir

Nitazoxanide DRUG

Evaluate the efficacy of Nitazoxanide in treatment of COVID-19

Also known as: Treatment

Nitazoxanide

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will include patients with confirmed COVID-19 infection and admitted to COVID-19 quarantine hospitals. Included patients should be \> 12 years old, with creatinine clearance \> 30 mL/ml, and without any malignancy. Patients with COVID-19 infection are classified clinically into mild, moderate, severe, and critical cases according to the management guide for COVID-19 published by the Egyptian Ministry of Health and Population. Mild cases are defined as patients in whom clinical symptoms are mild, and no pneumonia manifestations can be found in imaging. Moderate cases are defined as patients having symptoms such as fever and respiratory tract symptoms, etc. and pneumonia manifestations can be seen in imaging. Severe cases are patients who meet any of the following criteria; (a) respiratory rate \> 30 breaths/min, (b) oxygen saturations\< 93% at a rest state, (c) arterial partial pressure of oxygen (PaO2)/ Fraction of inspired oxygen (FiO2)\<300 mm Hg, or (d) patients with more than 50% lesions progression within 24 to 48 hours in lung imaging should be treated as severe cases. Finally, critical patients are those who are meeting any of the following criteria; (a) occurrence of respiratory failure requiring mechanical ventilation, or (b) the presence of shock; other organ failures that require monitoring and treatment in the ICU. All patients with an established diagnosis of COVID-19 in Egyptian quarantine hospitals at any clinical stage will be included in this study.

You may not qualify if:

• Patients \< 12 years old.
• Pregnant females.
• Patients with renal impairment with creatinine clearance \< 30 mL/min.
• Patients with malignancies particularly Hepatocellular Carcinoma (HCC).
• Patients using Favipiravir or Lopinavir-Ritonavir, as the co-administration of these drugs with Sofosbuvir/Ledipasvir has not been studied.
• Patients with decompensated liver cirrhosis (Child-Pugh score B and C).

Sponsors & Collaborators

• Assiut University: lead
• Helwan University: collaborator

Study Sites (2)

15th May Hospital

Helwan, Cairo Governorate, Egypt

Location

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (20)

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Related Links

• Epidemiological data about Covid-19

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination; Therapeutics; nitazoxanide

Study Officials

• Mohammed A Medhat, PhD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Mohamed El Kassas, PhD

  Helwan University

  STUDY CHAIR

• Haidi K Ramadan, PhD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: August 5, 2020
• Study Start: July 15, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)