The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients : A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2/3 Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine-artesunate (Artecom®) in COVID-19 Patients
<Stage 1> In Stage 1, the trial will be conducted in 20 participants for 28 days in a single arm, open-label design. Artecom® will be administered orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days.After the completion of the final participant in Stage 1, the DSMB will review the safety data from Stage 1 and determine whether to proceed to Stage 2.<Stage 2> In Stage 2, a total of 382 participants will be enrolled and randomized in a double blinded manner to receive either Artecom® or placebo (1:1 ratio) orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days.A second DSMB meeting and review of all available blinded safety data will occur after 191 participants have completed Day 28. A final DSMB meeting will be held after the completion of a study assessment by the last participant..
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
ClinicalTrials.gov - (2021) vom: 30. Sept. Zur Gesamtaufnahme - year:2021 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: January 8, 2021, Last downloaded: ClinicalTrials.gov processed this data on October 11, 2021, Last updated: October 13, 2021 |
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| Study ID: |
NCT04701606 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG00363244X |
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| 245 | 1 | 0 | |a The Safety and Efficacy of Pyronaridine-artesunate (Pyramax® or Artecom®)in COVID-19 Patients |b A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2/3 Clinical Trial to Evaluate the Safety and Efficacy of Pyronaridine-artesunate (Artecom®) in COVID-19 Patients |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: January 8, 2021, Last downloaded: ClinicalTrials.gov processed this data on October 11, 2021, Last updated: October 13, 2021 | ||
| 520 | |a <Stage 1> In Stage 1, the trial will be conducted in 20 participants for 28 days in a single arm, open-label design. Artecom® will be administered orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days.After the completion of the final participant in Stage 1, the DSMB will review the safety data from Stage 1 and determine whether to proceed to Stage 2.<Stage 2> In Stage 2, a total of 382 participants will be enrolled and randomized in a double blinded manner to receive either Artecom® or placebo (1:1 ratio) orally once a day for 3 consecutive days. All subjects will be evaluated for efficacy and safety for 28 days.A second DSMB meeting and review of all available blinded safety data will occur after 191 participants have completed Day 28. A final DSMB meeting will be held after the completion of a study assessment by the last participant. | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 4 | |a Medical Condition: Covid19 | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a Phase: Phase 2, Phase 3 | |
| 650 | 4 | |a 610 | |
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