|
NCT04475107
|
The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients |
Completed |
Phase 2 |
Jul/09/2020 |
Apr/15/2021 |
- Alternative id - SP-PA-COV-201
- Interventions - Drug: Pyronaridine-Artesunate|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Korea University Ansan Hospital, Ansan, Korea, Republic of|Chungnam national University Hospital, Daejeon, Korea, Republic of|Inha University Hospital, Incheon, Korea, Republic of|Gangnam Severance Hospital, Seoul, Korea, Republic of|Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|Kyungpook National University Hospital, Seoul, Korea, Republic of|National Medical Center, Seoul, Korea, Republic of|Sahmyook Medical Center, Seoul, Korea, Republic of|Seoul Medical Center, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of|The Catholic University of Korea, Eunpyeong St. Marys' Hospital, Seoul, Korea, Republic of|Ajou University Hospital, Suwon, Korea, Republic of
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 113
- Age - 19 Years and older (Adult, Older Adult)
- Outcome measures - Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*|Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline|Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*|Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline|Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline|Time to achieve normalization of body temperature, post-dose|Time to achieve normalization of respiratory rate, post-dose|Time to achieve normalization of oxygen saturation, post-dose
|
|
NCT04532931
|
COVID-19 Treatment in South Africa |
Completed |
Phase 2 |
Sep/03/2020 |
Aug/23/2021 |
- Alternative id - SP-PA-COV-202
- Interventions - Other: Standard of care (Paracetamol)|Drug: Artesunate-amodiaquine|Drug: Pyronaridine-artesunate|Drug: Favipiravir plus Nitazoxanide|Drug: Sofosbuvir/daclatasvir
- Study type - Interventional
- Study results - No Results Available
- Locations - Ezintsha, Wits Reproductive Health & HIV Institute University of the Witwatersrand, Johannesburg, South Africa
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 192
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Incidence of SARS-CoV-2 clearance|Time to clearance of nasal SARS-CoV-2|Median quantity of SARS-CoV-2|Proportion of days with fever after randomization|Proportion of days with respiratory symptoms after randomization|FLU-PRO© Plus|Serious adverse events|Adverse events resulting in treatment discontinuation|Adverse events considered related to the investigational products|LRTI|Maximum score on WHO Ordinal Scale for Clinical Improvement during study participation|Cumulative incidence of hospitalization|Days of hospitalization|Cumulative incidence of mortality
|
|
NCT04701606
|
The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients |
Recruiting |
Phase 2|Phase 3 |
Mar/29/2021 |
Apr/15/2022 |
- Alternative id - SP-PA-COV-203
- Interventions - Drug: Artecom® (pyronaridine-artesunate)|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - De La Salle University Medical Center, Dasmariñas, Gov, D. Mangubat St, 4114 Cavite, Philippines|The Medical City, Pasig City, Ortigas Avenue, Barangay Ugong, Metro Manila, Philippines|Lung Center of the Philippines, Quezon City, Quezon Avenue, Quezon City, 1100 Philippines, Philippines|Philippine General Hospital, Manila, Taft Ave, Ermita, Manila, 1000 Metro, Philippines
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 402
- Age - 19 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants with clinical improvement as defined by an improvement of categories on the WHO Ordinal Scale of clinical status until Days 28.|Time to clinical improvement was defined as time from randomization to an improvement of categories on the WHO Ordinal Scale of clinical status.|Changes in the WHO Ordinal Scale for Clinical Improvement until Days 28 compared to Baseline.|Changes in National Early Warning Score (NEWS) until Days 28 compared to Baseline.|Proportion of participants with negative for COVID-19 as determined by real-time RT-PCR test until Days 14.|Changes in viral load until Days 14 compared to Baseline.|The time to body temperature normalization after the administration of investigational Product (IP).|The time to respiratory rate normalization after the administration of IP.|The time to oxygen saturation (SpO2) normalization after the administration of IP.|Mortality rate at Day 28.|Duration of hospitalization (Day 1 to Day 28).|The incidence of adverse events (AEs).|The incidence of serious adverse events (SAEs).
|
|
NCT04695197
|
Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso |
Recruiting |
Phase 3 |
Jan/08/2021 |
Jul/31/2023 |
- Alternative id - 20-063|202009642148520
- Interventions - Drug: Artemether-lumefantrine (AL)|Drug: Pyronaridine-artesunate (PA)
- Study type - Interventional
- Study results - No Results Available
- Locations - Ouagadougou Hospitals, Ouagadougou, Burkina Faso|Kisumu County Referral Hospital, Kisumu, Kenya
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 142
- Age - 6 Months to 100 Years (Child, Adult, Older Adult)
- Outcome measures - Incidence of SARS-CoV-2 clearance|Median viral load of SARS-CoV-2|Cumulative incidence of SARS-CoV-2 clearance|Time to clearance of nasal SARS-CoV-2|Cumulative seroconversion rates (IgG, IgM, IgA)|IgG, IgM, IgA antibody titres against SARS-CoV-2|IL-6, IL-7, IL-10, TNF-alpha and Interferon-Gamma|CRP and angiotensin-2, angiopoietin-1 and angiopoietin-2|Genomic responses to SARS-CoV-2 infection|Cellular immune responses to SARS-CoV-2 infection|The clinical and parasitological antimalarial treatment response|COVID-19 disease severity|COVID-19 disease duration|COVID-19 fever duration|COVID-19 respiratory symptoms duration|COVID-19 disease duration in days|Treatment-related adverse events, serious adverse events, and adverse events resulting in treatment discontinuation
|
