Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Nashat Abu Saleh, Yigal Blum*, Albert El-Roeiy, Yafit Stark, Kamal Abu Jabal and Frederic Deutch
Background: Novel medications for treating any SARS-CoV-2 variant and similar pandemic viruses are sought. Growing evidence connects coronavirus’ binding, fusion, and replication, as well as evolved acute pulmonary infections, with locally induced acidity. Stabilized Amorphous Calcium Carbonate (ACC) has demonstrated preclinical and clinical efficacies for treating biomedical conditions associated with pH modulation effects by delivering alkaline carbonate content to acidified environments.
Objectives: The study aimed to establish the safety, tolerability, and efficacy of ACC, named AMOR-18 (manufactured by Amorphical LTD), for treating hospitalized patients with moderate-to-severe SARS-CoV-2, administered as a combination of sublingual powder and inhaled suspensions alongside the Best Available Treatment (BAT).
Methods: A Phase 1/2 trial-a phase 1 (open label single arm study) expanded into a phase 2, multicenter, prospective, 1:1 randomized, double-blind, placebo-controlled, concomitantly with Best Available Treatment (BAT) was performed on hospitalized, moderate-to-severe COVID-19 patients. Patients in the active arm received four daily sublingually administered doses of 1,475 mg ACC powder and three inhaled doses of 370 mg ACC in 10 ml suspensions (total daily doses of 5.900 mg in the form of powder and 1,110 mg as a suspension of ACC). The intended primary efficacy outcomes were patient improvement rate, defined as a reduction of at least one point in an established eight-category Disease Ordinal Scale (DOS), used in COVID-19 clinical trials; statistically significant reducing time from treatment to discharge; and statistically significant prevention of patient transfer to the Intensive Care Unit (ICU) and death.
Results: After a successful safety study with six patients in Stage 1, the double-blind study was performed on sixty patients that were equally randomized (30/30) to the active and placebo arms with similar DOS severity. The most significant outcome was the prevention of ICU transfer and death (0%) in the active arm compared to seven ICU transfers and three deaths in the placebo arm (23%; Fisher’s P=0.011). The patient improvement rate was significantly higher in the ACC (93%; 90% CI=82%-98%) compared to the placebo arm (73%; 90% CI=59%-84%) in the intention-to-treat sets. All patients in the active arm were discharged within 10 days from treatment initiation, and only one related adverse effect (constipation) was reported. There were no significant differences in responses by age, gender, comorbidities, and vaccination status.
Conclusion: This early clinical study demonstrates a clinically meaningful effect in treating moderate-to- severe COVID-19 patients with a combination of sublingually and inhaled doses of ACC, primarily preventing disease deterioration and death, as well as enhancing improvement and recovery rates.
Published Date: 2023-10-05; Received Date: 2023-09-04