Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Compared to Placebo and Best Available Care (BAT), for the Treatment of Moderate to Severe COVID-19 Patients.

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amorphical Ltd.

Criteria

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