Covid19 Clinical Trial
Official title:
A Phase 1/2 Prospective Randomized Placebo Controlled Study to Assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Administered Sublingual and in Inhalation Concomitantly With BAT (Best Available Care) as Compared to Placebo and BAT for the Treatment of Moderate to Severe COVID-19 Patients.
Verified date | February 2024 |
Source | Amorphical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase I/II study with Amorphous Calcium Carbonate (ACC) administered sublingual and in Inhalation concomitantly with BAT (Best Available Care) as Compared to Placebo and BAT for the treatment of Moderate to Severe COVID-19 patients. The purpose of this study is to assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC).
Status | Completed |
Enrollment | 66 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Males and females of age = 18 years and = 80 years 2. Signed an Informed Consent 3. Agree to undergo blood tests as per protocol 4. Diagnosed with COVID-19 5. Evidence of lung involvement (by chest X rays or lung US) 6. May or may not need for Supplemental Oxygen at enrollment 7. Hospitalized Exclusion Criteria: 1. Pregnant or breast-feeding females 2. Patients with non-COVID19 related Pneumonia 3. Any pulmonary disease not related to COVID19 4. Tracheostomy 5. High flow oxygen or non-invasive ventilation (Bipap) or Mechanical ventilation 6. Hypercalcemia defined as calcium or corrected calcium > 10.5mg/dL 7. Hyperphosphatemia defined as > 4.5mg/dL 8. Urine calcium to creatinine ratio >0.14 9. Participating in another clinical study |
Country | Name | City | State |
---|---|---|---|
Israel | Shamir MC | Be'er Ya'aqov | |
Israel | Tel-Aviv Sourasky MC | Tel Aviv | |
Israel | Ziv MC | Tsefat |
Lead Sponsor | Collaborator |
---|---|
Amorphical Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Severity rating of Disease using an 8-point ordinal scale on days 7, 14, 21, measured as improvement greater than or equal to 1 point from baseline score. | Ordinal 8 points scale:
Not hospitalized and no limitations of activities. Not hospitalized, with limitation of activities, home oxygen requirement, or both. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons). Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to Covid-19 or to other medical conditions). Hospitalized, requiring any supplemental oxygen. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices. Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Death. |
Treatment Day 1 to Day 21 or discharge from hospital, the earliest. | |
Secondary | Duration of Hospital stay | Time to discharge from hospital | Date of hospitalization to treatment day 21 or discharge, whichever comes first. | |
Secondary | Duration of ICU stay | Time patient is hospitalized in ICU, if applicable. | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. | |
Secondary | Duration of Mechanical Ventilation Use | Time the patient requires Mechanical Ventilation (if needed) | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. | |
Secondary | Duration of Oxygen Supplementation | Time the patient requires Oxygen Supplementation (if needed) | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. | |
Secondary | Duration of No Oxygen use | Time the patient does not require Oxygen Supplementation | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. | |
Secondary | % of patients to meet ordinal scale of 3 or less | Proportion of subjects hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons). | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. | |
Secondary | % of death | Proportion of subjects died during the study, if any. | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. | |
Secondary | Frequency and severity of adverse events | Screening to End of treatment day 21 or discharge, whichever comes first. | ||
Secondary | Number and percent of patients with hypercalcemia | Treatment days 4, 7, 11, 17 and 21. |
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