Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: SNG001: SNG001 will be dosed daily for 14 days as this was the duration of dosing in Phase I and II studies. With this dosing schedule data from the SG016 study in which hospitalized pa
Sponsors
National Institute of Allergy and Infectious Diseases
PPD Pharmaceutical Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. Individuals =18 years of age. 4.1.1.3 Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected =240 hours prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory. Participants must be expected to begin study treatment no more than 7 days from self-reported onset of COVID-19 related symptoms or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list: subjective fever or feeling feverish cough shortness of breath or difficulty breathing at rest or with activity sore throat body pain or muscle pain/aches fatigue headache chills nasal obstruction or congestion nasal discharge loss of taste or smell nausea or vomiting diarrhea documented temperature >38°C One or more of the following signs/symptoms present within 24 hours prior to study entry: subjective fever or feeling feverish cough shortness of breath or difficulty breathing at rest or with activity sore throat body pain or muscle pain/aches fatigue headache chills nasal obstruction or congestion nasal discharge nausea or vomiting diarrhea documented temperature >38°C Oxygenation saturation of =92% obtained at rest by study staff within 24 hours prior to study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition their oxygen saturation should be measured while on their standard home oxygen supplementation level. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest. Additional inclusion criteria as appropriate for the investigational agent For participants who are of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Reproductive potential is defined as: participant who has reached menarche participant who has not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) level =40 IU/mL or 24 consecutive months if an FSH result is not available participant who has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation,or bilateral salpingectomy) participant with no other clinical condition
Exclusion criteria
Exclusion criteria: History of or current hospitalization for COVID-19. For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected ?240 hours prior to study entry. Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. Use of any prohibited medication listed in section 5.4.1 and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study entry. Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry. Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry. This does not include drugs approved for other uses and taken for those uses. NOTE: This does not include COVID-19 vaccines. Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo. See relevant appendix. Any co-morbidity requiring surgery within 7 days prior to study entry, or that is considered life threatening in the opinion of the site investigator within 30 days prior to study entry. Additional exclusion criteria as appropriate for the investigational agent. Currently pregnant Currently breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if the investigational agent will prevent the composite endpoint of hospitalization due to any cause or death due to any cause through study day 28. Hospitalization is defined as =24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic.Timepoint: New Grade 3 or higher AE through 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative proportion of participants dying during the first 28 days of follow-up, and through to 24 and 72 weeks , and the cumulative proportion hospitalized/dying through to 24 weeks and through to 72 weeks will be analyzed in a similar manner to the phase III primary outcome.Timepoint: New Grade 2 or higher AE(s) by day 28 and through week 24 | — |
Countries
Argentina, Botswana, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Haiti, India, Kenya, Malawi, Mexico, Peru, Philippines, South Africa, Uganda, Ukraine, United States of America, Zambia, Zimbabwe
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceuticals Development India Private Limited
Outcome results
None listed