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Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530422
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Abdelsalam El-Gohary, Almaza Military Fever Hospital

Brief Summary:

Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies.

This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the standard treatment (hydroxychloroquine, oseltamivir and azithromycin).


Condition or disease Intervention/treatment Phase
Covid19 Drug: Sofosbuvir plus Ledipasvir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This randomized controlled clinical trial is a prospective, comparative, single blind, randomized study that was conducted on 250 patients, divided into two equal groups. The group I received Sofosbuvir plus Ledipasvir and Group II received Oseltamivir, hydroxychloroquine "HCQ" plus Azithromycin (the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19)
Masking: Single (Participant)
Masking Description: Randomization applied through computer-generated number and concealed using sequentially numbered, sealed opaque envelope to assign the patient to group 1 either group 2
Primary Purpose: Treatment
Official Title: Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment
Actual Study Start Date : April 15, 2020
Actual Primary Completion Date : July 8, 2020
Actual Study Completion Date : July 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: • Group I (Sofosbuvir plus Ledipasvir)
Patients assigned to this group (125 patients) were received Sofosbuvir plus Ledipasvir, once daily for 15 to 21 days as minimum and maximum duration of therapy, respectively.
Drug: Sofosbuvir plus Ledipasvir

Sofosbuvir plus Ledipasvir, once daily for 15 to 21days

  • Oseltamivir 150 mg q 12 hours for 10 days ;
  • HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
  • Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
Other Name: Oseltamivir plus Hydroxychloroquine & Azithromycin

Active Comparator: Group II (Oseltamivir plus HCQ & Azithromycin)

Patients in this group (125 patients) were received the local medical committee of Almaza Fever Hospital guided standard treatment protocol for COVID-19:

  • Oseltamivir 150 mg q 12 hours for 10 days ;
  • HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
  • Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
  • Additional conservative medications were also given. Patients were evaluated as scheduled on day 0, 5 & 11 clinically
Drug: Sofosbuvir plus Ledipasvir

Sofosbuvir plus Ledipasvir, once daily for 15 to 21days

  • Oseltamivir 150 mg q 12 hours for 10 days ;
  • HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
  • Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days.
Other Name: Oseltamivir plus Hydroxychloroquine & Azithromycin




Primary Outcome Measures :
  1. Therapeutic success (cured) [ Time Frame: 21 days ]
    Cured: Documented virological clearance in 2 samples at least 24 hours apart.

  2. 28 days in hospital mortality [ Time Frame: 28 days ]
    any incidence of deaths for any participant within 28 days from starting the treatments


Secondary Outcome Measures :
  1. Percentage of clinical failure of treatments [ Time Frame: 21 Days ]
    participants who failed to achieve documented virological clearance in 2 samples at least 24 hours apart.

  2. Length of hospital stay [ Time Frame: Through study completion, an average of 14 weeks ]
    days of length of hospital staying in isolation till documented virological clearance in 2 samples at least 24 hours apart.

  3. Incidence of side effects [ Time Frame: 21 days ]
    Incidence of any side effects known to be related to the medication administrated either in group 1 or 2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pneumonic patients with SARS-COV-2 infection confirmed to be positive by RT-PCR; and demonstrated moderate cases criteria (fever "measured temperature of at least 38 °C", lower respiratory symptoms "cough, shortness of breath" and imaging-confirmed pneumonia").
  • Female patients enrolled in the study should have no planned pregnancy for 6 months, after participating in the study, with administration of proper contraceptive measures within 30 days from the first therapeutic dose of the investigational drugs.
  • Patients agreed to sign an informed consent to participate in the current study and that they would not participate in other clinical trials within 30 days from the last administration of the study drugs.

Exclusion Criteria:

  • Severe COVID-19 patients who met one of the following conditions: (1) Respiratory rate (RR) ≥ 30 times / min; (2) SaO2 / SpO2 ≤ 93% in resting state; (3) arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) ≤ 300 mmHg
  • Critical COVID-19 patients with one of the following conditions: (1) respiratory failure and need mechanical ventilation; (2) shock; (3) other organ failure combined with ICU treatment; severe liver disease (such as child Pugh score ≥ C, AST > 5 times upper limit);
  • Patients with contraindications specified for sofosbuvir- ledipasvir; the pregnancy test of female subjects during the screening period was positive, the researchers judged that the patient was not suitable to participate in this clinical study due to devastating co-morbid diseases (e.g. de-compensated liver disease, congested heart failure, chronic kidney disease, malignant or hematological disease under therapy or 3 months ago) and patients received antiviral eradication therapy for hepatitis C or B viruses within the previous 6 months.
  • Patients with chloroquine contra-indications: QTc > 500 m/sec, myasthenia gravis, porphyria, retinal pathology, epilepsy, G6PD deficiency, allergy to 4-aminoquinolone, chronic heart, kidney or liver disease, and arrhythmias.
  • Any patient demonstrates worsening of symptoms, radiological progression with virologically persistence within at least 5 days of the therapeutic evaluation period of the study after exclusion of cytokine storm was considered as a clinical failure and was shifted to the other management protocol.
  • Treatment was terminated at any time by a multidisciplinary team if a serious side effect occurred, which was attributed to the medications used ,e.g. cardiac arrhythmia, deteriorated liver or kidney function or unfortunately patient died .

Information from the National Library of Medicine

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): NCT04530422


Locations
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Egypt
Almaza Military Fever Hospital
Cairo, Egypt
Sponsors and Collaborators
Almaza Military Fever Hospital
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Responsible Party: Mohamed Abdelsalam El-Gohary, Head of Almaza Military Fever Hospital, Almaza Military Fever Hospital
ClinicalTrials.gov Identifier: NCT04530422    
Other Study ID Numbers: 14
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohamed Abdelsalam El-Gohary, Almaza Military Fever Hospital:
SARS-COV-2
Covid-19
Sofosbuvir- Ledipasvir
Hydroxychloroquine
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Sofosbuvir
Oseltamivir
Ledipasvir
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antiviral Agents