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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).
This study includes two parts:
Part 1 - A training period of a single arm active treatment open label, to assess the optimal method of study drug administration, as well as the safety of the combined administration, on 5 patients.
Following DSMB review of the data collected in part 1 and the DSMB approval to proceed to next part, part 2 will be initiated.
Part 2 - A randomized (1:1) placebo controlled 2 arms study. Additional 95 patients will be recruited to this arm.
Patients who are hospitalized due to moderate or severe COVID-19 will be recruited to this study.
The following elements are the main elements that will be assessed:
The whole study period per patient will be 22 days (21 treatment days) or until the patient has recovered and/or is discharged from the hospital, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMOR 18 Powder & Inhalation | Experimental | AMOR_inhaled Double Pack- Each kit contains two tubes that after mixing result with 1.14 % ACC in 10 ml suspension. AMOR_powder- ACC in a dry powder (up to 2000mg Calcium/day sublingually). |
|
| Placebo | Placebo Comparator | Placebo_Inhaled Double Pack - Each kit contains two tubes of saline at different volumes (similar to investigational product) after mixing the results remains saline at a final volume of 10ml. Placebo_Powder: Each sachet contains powder at the same particle size and weight as the powder of the investigational product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMOR 18 Powder & Inhalation | Drug | AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Treatment Day 1 to Day 21 or discharge from hospital, the earliest. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospital stay | Time to discharge from hospital | Date of hospitalization to treatment day 21 or discharge, whichever comes first. |
| Duration of ICU stay | Time patient is hospitalized in ICU, if applicable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir MC | Be’er Ya‘aqov | Israel | ||||
| Ziv MC |
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| Placebo | Drug | Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual |
|
| Treatment Day 1 to treatment day 21 or discharge, whichever comes first. |
| 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. |
| Duration of Oxygen Supplementation | Time the patient requires Oxygen Supplementation (if needed) | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. |
| 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. |
| % 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. |
| % of death | Proportion of subjects died during the study, if any. | Treatment Day 1 to treatment day 21 or discharge, whichever comes first. |
| Frequency and severity of adverse events | Screening to End of treatment day 21 or discharge, whichever comes first. |
| Number and percent of patients with hypercalcemia | Treatment days 4, 7, 11, 17 and 21. |
| Safed |
| Israel |
| Tel-Aviv Sourasky MC | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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