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.

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:

• Confirmation SARS-CoV-2 infection
• Respiratory Function (breathing rate, SpO2 Oxygen Saturation
• Vital Signs (BP, HR), Temperature
• Blood Tests
• Disease Severity Scale (8 points ordinal scale)

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.

Inclusion criteria

• Males and females of age ≥ 18 years and ≤ 80 years
• Signed an Informed Consent
• Agree to undergo blood tests as per protocol
• Diagnosed with COVID-19
• Evidence of lung involvement (by chest X rays or lung US)
• May or may not need for Supplemental Oxygen at enrollment
• Hospitalized

Exclusion criteria

• Pregnant or breast-feeding females
• Patients with non-COVID19 related Pneumonia
• Any pulmonary disease not related to COVID19
• Tracheostomy
• High flow oxygen or non-invasive ventilation (Bipap) or Mechanical ventilation
• Hypercalcemia defined as calcium or corrected calcium > 10.5mg/dL
• Hyperphosphatemia defined as > 4.5mg/dL
• Urine calcium to creatinine ratio >0.14
• Participating in another clinical study