Status:
COMPLETED
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.
Lead Sponsor:
Amorphical Ltd.
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 treatmen...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04900337
Start Date
February 9 2021
End Date
June 30 2023
Last Update
February 28 2024
Active Locations (3)
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1
Shamir MC
Be’er Ya‘aqov, Israel
2
Ziv MC
Safed, Israel
3
Tel-Aviv Sourasky MC
Tel Aviv, Israel