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Clinical Trials/DRKS00022203
DRKS00022203
Recruiting
Phase 2

Efficacy & Safety of Sofosbuvir/Daclatasvir treatment in COVID-19: A randomized, controlled study

PHARCO CORPORATE0 sites90 target enrollmentJune 15, 2020
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ConditionsCOVID-19SARS-nCoV-2 infection

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
COVID-19SARS-nCoV-2 infection
Sponsor
PHARCO CORPORATE
Enrollment
90
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 15, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
PHARCO CORPORATE

Eligibility Criteria

Inclusion Criteria

  • •(1\) Subjects or their legal representatives have signed the informed consent form (ICF).
  • •(2\) Subjects are aged \= 18 and \= 75;
  • •(3\) Has laboratory\-confirmed Symptomatic COVID\-19 (SARS\-CoV\-2 infection) as determined by polymerase chain reaction (PCR) assay in any specimen collected \< 72 hours prior to randomization and any clinical severity category of the following:
  • •A. Mild: mild clinical symptoms with no picture of pneumonia in CT, but positive 2019\-nCoV2 in throat/nasal swabs.
  • •B. Moderate: fever, respiratory symptoms, etc., pneumonia visible in CT.
  • •C. Severe (Not Critical): meeting any of the following criteria:
  • •(a) Respiratory distress, RR\=30 times/min;
  • •(b) Finger oxygen saturation \=93% in rest state;
  • •(c) Arterial partial pressure of oxygen / concentration of fractional inspired oxygen (PaO2/FiO2\) \=400mmHg and \> 200mmHg under oxygen inhalation.

Exclusion Criteria

  • •(1\) Patients with pneumonia due to other etiology.
  • •(2\) Critically severe COVID19 ARDS cases Requiring invasive mechanical ventilation at screening;
  • •(3\) Patients who have severe concomitant illness that affects survival or course of the disease, including uncontrolled malignant tumor, HIV, blood dyscrasia, active bleeding or patients with shock/or multiple organ failure at screening.
  • •(4\) Pregnant or lactating females.
  • •(5\) Hypersensitivity or contraindication to any of the experimental drugs used in the study (Prolonged QT syndrome, G6PD deficiency, psoriasis, retinal damage or others). .
  • •(6\) Patients with decompensated liver cirrhosis or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase (ALT) and aspartate aminotransferase (AST);
  • •(7\) Renal dysfunction (estimated glomerular filtration rate \[eGFR] \<30 mL/min/1\.73m2\);

Outcomes

Primary Outcomes

Not specified

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