Covid19Phase 2NCT04480138
Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)
A Phase 2 study testing Pegylated Interferon-α2b in people with Covid19, run by Zydus Lifesciences Limited at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Pegylated Interferon-α2b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesMexico
- Study dates
- 11 Aug 2020to 21 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male or non-pregnant females, ≥18 years of age at the time of enrolment.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
- Patients with SpO2 > 93% and respiratory rate <30 breaths/min.
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- Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray)
- Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
- Women of childbearing potential must agree to use at least one primary form of contraception
Who cannot join
- ALT/AST >5 times the upper limit of normal.
- Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
- Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
- Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
- Pregnant or breast feeding.
- Allergy to any study medication or usage of test drug during last 14 days prior to screening
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- 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.
- Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
- Prolong QT interval (>450 ms).
Trial locations and contacts
2 sites in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Pegylated Interferon-α2b, Standard of Care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon-α2bDrug
1 mcg/kg on day 1 and day 8 after safety evaluations.
Standard of CareOther
Standard of care as per local authority
| Study group | Role | What they receive |
|---|---|---|
| Pegylated Interferon-α2b + Standard of care | Experimental | Test :- Pegylated Interferon-α2b + Standard of care (SOC)
Pegylated Interferon-α2b-Initial 1 mcg/kg 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 along with the recommended standard of care at the time of conduct of trial. Receives: Drug: Pegylated Interferon-α2b; Other: Standard of Care |
| Standard of Care | Active comparator | Control: Standard of care
Standard of care treatment will be provided as per regulatory recommendation and approval. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical status of subject on a 7-point ordinal scale
- Not hospitalized, no limitations on activities.
- Not hospitalized, limitation on activities.
- Hospitalized, not requiring supplemental oxygen.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, on non-invasive ventilation or high flow oxygen devices.
- Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Death.
Measured: Week 2
Secondary outcomes (11)
PCR test
PCR for SARS-CoV-2 in pharyngeal swab
Measured: Week 2 and Week 4
Supplemental Oxygen
Occurrence of supplemental Oxygen
Measured: Week 2 and Week 4
Mechanical Ventilation
Occurrence of Mechanical Ventilation
Measured: Week 2 and Week 4
Incidence of Treatment-Emergent Adverse Events
Occurence of Adverse events
Measured: Week 2 and Week 4
C-reactive protein (CRP)
Inflammatory Biomarker
Measured: Week 2 and Week 4
Interleukin 6 (IL-6)
Inflammatory Biomarker
Measured: Week 2 and Week 4
D-dimer
Inflammatory Biomarker
Measured: Week 2 and Week 4
Interferon gamma
type II class of interferons
Measured: Week 2 and Week 4
Ferritin
proteins
Measured: Week 2 and Week 4
TNF alpha
Inflammatory Biomarker
Measured: Week 2 and Week 4
Interleukin 1-β
Inflammatory Biomarker
Measured: Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start11 Aug 2020
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Due to non availability of eligible subjects and slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Deven Parmar, MD, Study director, Cadila Healthcare Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480138
- Sponsor's protocol ID
- PEGI.20.003
- Status last verified
- Jun 2021
- First submitted
- 20 Jul 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04480138
- Acronym / sponsor ID
- PEGI.20.003
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to non availability of eligible subjects and slow recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegylated Interferon-α2b + Standard of care | Experimental | Drug: Pegylated Interferon-α2b, Other: Standard of CareTest :- Pegylated Interferon-α2b + Standard of care (SOC) Pegylated Interferon-α2b-Initial 1 mcg/kg 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 along with the recommended standard of care at the time of conduct of trial. |
| Standard of Care | Active comparator | Other: Standard of CareControl: Standard of care Standard of care treatment will be provided as per regulatory recommendation and approval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male or non-pregnant females, ≥18 years of age at the time of enrolment.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
Key exclusion criteria (9 listed)
- ALT/AST >5 times the upper limit of normal.
- Patients with respiratory rate <20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
- Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
- Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30 mL/min/1.73 m2).
- Pregnant or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Interferon-α2b1 mcg/kg on day 1 and day 8 after safety evaluations. | Drug | Pegylated Interferon-α2b + Standard of care |
| Standard of CareStandard of care as per local authority | Other | Pegylated Interferon-α2b + Standard of care, Standard of Care |
Primary outcome
Change in Clinical status of subject on a 7-point ordinal scale
Time frame: Week 2
1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 7. Death.
11 secondary outcomes
PCR test
Time frame: Week 2 and Week 4
Supplemental Oxygen
Time frame: Week 2 and Week 4
Mechanical Ventilation
Time frame: Week 2 and Week 4
Incidence of Treatment-Emergent Adverse Events
Time frame: Week 2 and Week 4
C-reactive protein (CRP)
Time frame: Week 2 and Week 4
Interleukin 6 (IL-6)
Time frame: Week 2 and Week 4
D-dimer
Time frame: Week 2 and Week 4
Interferon gamma
Time frame: Week 2 and Week 4
Ferritin
Time frame: Week 2 and Week 4
TNF alpha
Time frame: Week 2 and Week 4
Interleukin 1-β
Time frame: Week 2 and Week 4
Results and safety
The study was stopped early (reason given: Due to non availability of eligible subjects and slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Deven Parmar, MD study director
Cadila Healthcare Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Interferon-α2b in people with Covid19, run by Zydus Lifesciences Limited at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to non availability of eligible subjects and slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical status of subject on a 7-point ordinal scale (time frame: Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.