None listed
Conditions
Interventions
LY3819253 Type of group
Participants in this study will be randomized to receive the research product, administered by intravenous infusion.
Group name:Placebo de LY3819253 Type of group
Participants in this study will be randomized to receive the placebo of LY3819253 (0.9% Sodium Chloride Solution), administered by intravenous infusion.
Sponsors
Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Ability and willingness of participant (or legally authorized representative) to provide informed consent. 2) Individuals ≥18 years of age. 3) Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected ≤168 hours prior to study entry. 4) Participants must be expected to begin study treatment no more than 10 days from self-reported onset of COVID-19 related symptoms or measured fever. 5) One or more of the following signs/symptoms present within 48 hours prior to study entry (fever, cough, shortness of breath or difficulty breathing, sore throat, body pain, fatigue, headache, etc.) 6) Oxygenation saturation of ≥92% obtained at rest by study staff within 48 hours prior to study entry. 7) 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 8) Additional inclusion criteria as appropriate for the investigational agent. For more details check the protocol.
Exclusion criteria
Exclusion criteria: 1) History of or current hospitalization for COVID-19 2) Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. 3) Use of any prohibited medication listed in the protocol within 30 days prior to study entry. 4) Receipt of convalescent COVID-19 plasma treatment at any time prior to study entry. 5) Receipt of a SARS-CoV-2 vaccine at any time prior to study entry. 6) Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry. 7) Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry 8) Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo 9) Any co-morbidity requiring surgery within 7 days prior to study entry 10) Additional exclusion criteria as appropriate for the investigational agent. For more details check the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Duration of targeted COVID-19 associated symptoms from start of investigational agent (day 0) based on self-assessment. Duration defined as the last day on or before study day 28 when any symptoms scored as moderate or severe at study entry (pre-treatment) are still scored as moderate or severe (i.e., not mild or absent), or any symptoms scored as mild or absent at study entry are scored as mild or worse (i.e., not absent). The targeted symptoms are 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 (runny nose), nausea or vomiting, and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1) moderate (2) and severe (3). Measure:Clinical: Duration of COVID-19 symptoms (Phase 2) Timepoints:Up to Day 28 ; Outcome name:At each of days 3, 7, 14, 21 and 28, detection (detectable versus undetectable) of SARS-CoV-2 RNA from site-collected NP swabs. Measure:Virologic: Detection of SARS-CoV-2 RNA (Phase 2) Timepoints:Days 3, 7, 14, 21 and 28. ; Outcome name:New Grade 3 or higher AE through 28 days. Measure:Safety: New Grade 3 o higher (Phase 2) Timepoints:Through 28 days. ; Outcome name:Death from any cause or hospitalization during the 28-day period from and including the day of the first dose of investigational agent or placebo. 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 Measure:Efficacy: Death from any cause or hospitalization during the 28-day period from and including the day of the first dose of investigational agent or placebo. (Phase 3) Timepoints:During the 28-day period from and including the day of the first dose ; Outcome name:New Grade 3 or hi | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Phases II and III: Detection (detectable versus undetectable) and level of SARSCoV- 2 RNA from participant-collected nasal swabs through day 28. Measure:Phases II and III: Detection (detectable versus undetectable) and level of SARSCoV- 2 RNA through day 28. Timepoints:Through day 28. ; Outcome name:For participants who are alive at 28 days and not previously hospitalized, the severity ranking will be based on their area under the curve AUC of the symptom score associated with COVID-19 disease over time (through 28 days counting day 0 as the first day) defined as the sum of scores for the targeted symptoms in the participant’s study diary (each individual symptom is scored from 0 to 3). Participants who are hospitalized or who die during follow-up through 28 days will be ranked as worse than those alive and never hospitalized as follows (in worsening rank order): alive and not hospitalized at 28 days; hospitalized but alive at 28 days; and died at or before 28 days. Measure:Phases II and III: COVID-19 severity ranking based on symptom severity scores over time during the 28-day period from and including the day of the first dose of investigational agent or placebo, hospitalization, and death. Timepoints:During the 28-day period from and including the day of the first dose of investigational agent or placebo ; Outcome name:Follow up of the Progression through day 28 of one or more COVID-19-associated symptoms to a worse status than recorded in the study diary at study entry, prior to start of investigational agent or placebo Measure:Phases II and III: Progression through day 28 of one or more COVID-19- associated symptoms to a | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, India, Kenya, Mexico, Philippines, South Africa, Uganda, United States
Contacts
Public ContactDario Diaz
PPD Peru S.A.C.
Outcome results
None listed