Status:
UNKNOWN
Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19
Lead Sponsor:
Genova Inc.
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed wi...
Eligibility Criteria
Inclusion
- Signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.
- Men and women, ≥18 years of age at time of enrollment.
- Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if RT-PCR test result not available only at the time of screening).
- Less than or equal to 9 days from COVID-19 symptom onset to starting treatment.
- • Symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other COVID-19 symptoms as determined by the Investigator.
- Hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (WHO category 4 or 5)
- Female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. Male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. For a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to Appendix 1.
Exclusion
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
914 Patients enrolled
Trial Details
Trial ID
NCT04669015
Start Date
June 10 2021
End Date
August 1 2022
Last Update
June 3 2022
Active Locations (88)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Interzonal General de Agudos Dr Jose Penna
Bahía Blanca, Argentina
2
Clinica Zabala
Buenos Aires, Argentina
3
CEMIC
Ciudad Autonoma Buenos Aires, Argentina
4
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, Argentina