COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=64299

Rashmi Chitgupi

rashmi.chitgupi@ppdi.com

2022-01-14

Not recruiting

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. <br/ > <br/ > 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. <br/ > <br/ > 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: <br/ > subjective fever or feeling feverish <br/ > <br/ > cough <br/ > <br/ > shortness of breath or difficulty breathing at <br/ > rest or with activity <br/ > <br/ > sore throat <br/ > <br/ > body pain or muscle pain/aches <br/ > <br/ > fatigue <br/ > <br/ > headache <br/ > <br/ > chills <br/ > <br/ > nasal obstruction or congestion <br/ > <br/ > nasal discharge <br/ > <br/ > loss of taste or smell <br/ > <br/ > nausea or vomiting <br/ > <br/ > diarrhea <br/ > <br/ > documented temperature >38°C <br/ > <br/ > One or more of the following signs/symptoms present within 24 hours prior to study entry: <br/ > <br/ > subjective fever or feeling feverish <br/ > <br/ > cough <br/ > <br/ > shortness of breath or difficulty breathing at rest or with activity <br/ > <br/ > sore throat <br/ > <br/ > body pain or muscle pain/aches <br/ > <br/ > fatigue <br/ > <br/ > headache <br/ > <br/ > chills <br/ > <br/ > nasal obstruction or congestion <br/ > <br/ > nasal discharge <br/ > <br/ > nausea or vomiting <br/ > <br/ > diarrhea <br/ > <br/ > documented temperature >38°C <br/ > <br/ > 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. <br/ > <br/ > 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. <br/ > <br/ > Additional inclusion criteria as appropriate for the investigational agent <br/ > <br/ > 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. <br/ > <br/ > Reproductive potential is defined as: <br/ > participant who has reached menarche <br/ > 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 <br/ > available participant who has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal <br/ > liga

History of or current hospitalization for COVID-19. <br/ > <br/ > 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 Ë?240 hours prior to study entry. <br/ > <br/ > Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. <br/ > <br/ > 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. <br/ > <br/ > Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry. <br/ > <br/ > 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: <br/ > This does not include COVID-19 vaccines. <br/ > <br/ > Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo. See relevant appendix. <br/ > <br/ > 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. <br/ > <br/ > Additional exclusion criteria as appropriate for the investigational agent. <br/ > <br/ > Currently pregnant <br/ > Currently breastfeeding <br/ >

3

National Institute of Allergy and Infectious Diseases

18

99

Argentina;Botswana;Brazil;India;Canada;Chile;Colombia;Costa Rica;Ecuador;Guatemala;Haiti;Kenya;Malawi;Mexico;Peru;Philippines;South Africa;Uganda;Ukraine;United States;Zambia;Zimbabwe

Mild disease at enrollment

1: Mild disease at enrollment

2200

To determine if the investigational agent will prevent the composite <br/ >endpoint of hospitalization due to any cause or death due to any cause through <br/ >study day 28. Hospitalization is defined as â?¥24 hours of acute care; in a hospital <br/ >or similar acute care facility; including Emergency Rooms or temporary facilities <br/ >instituted to address medical needs of those with severe COVID-19 during the <br/ >COVID-19 pandemic.Timepoint: New Grade 3 <br/ >or higher AE <br/ >through 28 <br/ >days

Phase 3

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