From the PR The purpose of this clinical trial
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Posted On: 06/21/2021 11:04:20 AM
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From the PR
The purpose of this clinical trial was to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms (> 12 weeks) of COVID-19. The primary outcome was change from baseline in daily COVID-19-related symptom severity score through Day 56. Secondary outcomes included progression (or worsening) of COVID-19-associated symptoms through Day 56 compared to baseline. Patient symptoms were self-reported daily throughout the 56-day evaluation period and reported electronically. The symptom scores were rated as severe, moderate, mild, and none.
From : https://www.drugwatch.com/fda/clinical-trials/
Phase 1 Trials
This phase occurs directly after lab testing. Based on the lab testing, researchers have determined that the drug, device or other treatment may provide a benefit to humans. However, at this point, it has not yet been determined how the drug will affect or react to a human’s biology, or whether it’s safe or even effective. Phase 1 usually consists of a very small number of participants — either mostly healthy subjects or patients, such as terminal cancer patients — and is conducted to evaluate the drug’s overall safety and determine the safest dose of the drug.
The purpose of this clinical trial was to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms (> 12 weeks) of COVID-19. The primary outcome was change from baseline in daily COVID-19-related symptom severity score through Day 56. Secondary outcomes included progression (or worsening) of COVID-19-associated symptoms through Day 56 compared to baseline. Patient symptoms were self-reported daily throughout the 56-day evaluation period and reported electronically. The symptom scores were rated as severe, moderate, mild, and none.
From : https://www.drugwatch.com/fda/clinical-trials/
Phase 1 Trials
This phase occurs directly after lab testing. Based on the lab testing, researchers have determined that the drug, device or other treatment may provide a benefit to humans. However, at this point, it has not yet been determined how the drug will affect or react to a human’s biology, or whether it’s safe or even effective. Phase 1 usually consists of a very small number of participants — either mostly healthy subjects or patients, such as terminal cancer patients — and is conducted to evaluate the drug’s overall safety and determine the safest dose of the drug.
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