A Phase III, Randomized, Controlled, Open-Label Studyto Evaluate the Efficacy and Safety of PegylatedInterferon Alfa-2b In the Treatment of Adult PatientsDiagnosed With SARS-CoV-2 (COVID-19).

Zydus Research Center Cadila Healthcare Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Ability to comprehend and willingness to sign a written ICF for the study.
•2. Male or non-pregnant females, >=18 years of age at the time of enrolment.
•3. Understands and agrees to comply with planned study procedures.
•4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
•5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR within 5 days of
•enrollment.
•6. Patients with pneumonia with no signs of severe disease, respiratory rate >=24breaths/minute,
•SpO2 90%- 94%.
•7. Illness of any duration, and at least one of the following:
•a. Radiographic infiltrates by imaging (chest x-ray/CT scan)
•b. Clinical assessment (evidence of rales/crackles or other clinical symptoms related to COVID-19 on examination).
•8. Women of childbearing potential must agree to use at least one primary form of contraception
•for the entire duration of the study (acceptable methods will be determined by the site).

•1. ALT/AST >5 times the upper limit of normal.
•2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
•3. Pregnant or breast feeding.
•4. Allergy to any study medication.
•5. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigatorâ??s assessment.
•6. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
•7. Prolong QT interval ( >450 ms).

发起方

Zydus Research Center Cadila Healthcare Limited