Clinical trial NCT04480138: Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
Official title: A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: Zydus Lifesciences Limited
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.

Detailed description: This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

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 PCR, or other commercial or public health assay in any specimen within one week
6. Patients with SpO2 \> 93% and respiratory rate \<30 breaths/min.
7. Illness of any duration, and at least one of the following:

   1. Radiographic infiltrates by imaging (chest x-ray)
   2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
8. Women of childbearing potential must agree to use at least one primary form of contraception

Exclusion Criteria:

1. ALT/AST \>5 times the upper limit of normal.
2. Patients with respiratory rate \<20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
3. Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
4. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30 mL/min/1.73 m2).
5. Pregnant or breast feeding.
6. Allergy to any study medication or usage of test drug during last 14 days prior to screening
7. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
8. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
9. Prolong QT interval (\>450 ms).

Primary outcomes:
measure: Change in Clinical status of subject on a 7-point ordinal scale
timeFrame: Week 2
Secondary outcomes:
measure: PCR test
timeFrame: Week 2 and Week 4
measure: Supplemental Oxygen
timeFrame: Week 2 and Week 4
measure: Mechanical Ventilation
timeFrame: Week 2 and Week 4
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Week 2 and Week 4
measure: C-reactive protein (CRP)
timeFrame: Week 2 and Week 4
measure: Interleukin 6 (IL-6)
timeFrame: Week 2 and Week 4
measure: D-dimer
timeFrame: Week 2 and Week 4
measure: Interferon gamma
timeFrame: Week 2 and Week 4
measure: Ferritin
timeFrame: Week 2 and Week 4
measure: TNF alpha
timeFrame: Week 2 and Week 4
measure: Interleukin 1-β
timeFrame: Week 2 and Week 4
Other outcomes:
Locations:
city: Zapopan
country: Mexico
facility: Avant Sante site 2
state: Jalisco
city: Monterrey
country: Mexico
facility: Avant Sante Site 1
Study officials:
affiliation: Cadila Healthcare Ltd.
name: Dr Deven Parmar, MD
role: STUDY_DIRECTOR
References: