- Alternative id - MP1032-CT05|2021-000344-21
- Interventions - Drug: MP1032|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Snake River Research PLLC, Idaho Falls, Idaho, United States|Richmond University Medical Center, Staten Island, New York, United States|MHAT Dr. Stamen Iliev AD, Montana, Bulgaria|SHATPD Pernik EOOD, Pernik, Bulgaria|"Second Multiprofile Hospital For Active Treatment - Sofia" Ead, Sofia, Bulgaria|Umhatem"N.I.Pirogov", Sofia, Bulgaria|SHATPPD Sata Zagora EOOD, Stara Zagora, Bulgaria|Centre Hospitalier Victor Dupouy, Argenteuil, France|CHU de Grenoble Alpes, Grenoble Cedex 9, France|Centre Hospitalier Lyon Sud, Pierre-Benite CEDEX, France|DE KK Infektológiai Klinika, Debrecen, Hungary|Flor Ferenc Hospital of Pest County, Kistarcsa, Hungary|IRCCS Ospedale San Raffaele, Milan, Italy|Polo Universitario - L'Azienda Ospedaliera Luigi Sacco, Milan, Italy|Policlinico Agostino Gemelli, Roma, Italy|Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes", Bucharest, Romania|Spitalul Municipal Caracal, Caracal, Romania|Spitalul Clinic de Boli Infectioase "Sfanta Parascheva", Iaşi, Romania|Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou", Suceava, Romania|Clinica Anestezie si Terapie Intensiva, Timişoara, Romania|Hospital Clinic de Barcelona Hospital Clinic i Provincial, Barcelona, Spain|Hospital Ramon y Cajal, Edificio Central, Madrid, Spain|Hospital Clínico Universitario de Salamanca, Salamanca, Spain|Hospital Universitario Marqués de Valdecilla/IDIVAL, Santander, Spain|Hospital Universitario de Valme, Sevilla, Spain|Hospital Álvaro Cunqueiro, Vigo, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 120
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Percentage of Participants with Disease Progression at Day 14|Percentage of Participants with Disease Progression at Day 28|Percentage of Participants with Disease Resolution at Day 28|All-cause Mortality Rate at Day 28|Change from Baseline in Clinical Status related to COVID-19 according to the NIAID 8-point Ordinal Scale at Day 28|Percentage of Participants with Disease Resolution at Day 14|All-cause Mortality Rate at Day 14 and Day 60|Change from Baseline in Clinical Status related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14|Percentage of Participants requiring Invasive Ventilation (Mechanical Ventilator and/or ECMO), or who are not Alive on Day 14 and Day 28|Percentage of Participants in each category of the NIAID 8-point Ordinal Scale|Time to (First) Improvement of at least 1 Category on the NIAID 8-point Ordinal Scale|The Odds Ratio for the Number of Participants with Clinical Status Improvement From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28|Total Duration of Hospitalization at Day 28 and Day 60|Percentage of Participants alive and testing negative for COVID-19 at Day 14, Day 28, and Day 60|Number of Participants with treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Number of Participants with Vital Sign Abnormalities|Number of Participants With Physical Examination Findings|Number of Participants with Laboratory Findings|Maximum Observed Plasma Concentration (Cmax) of MP1032|Area Under the Plasma Concentration-time curve from Time Zero (pre-dose) to last non-zero concentration (AUC0-t) of MP1032|Apparent Elimination Rate Constant (K) of MP1032|Apparent Body Clearance (CL) of MP1032|Apparent Volume of Distribution (Vd) of MP1032|Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032|Average Observed Plasma Concentration at Steady State of MP1032
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