Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: a randomized clinical trial

Siami, Zeinab; Aghajanian, Sepehr; Mansouri, Somayeh; Mokhames, Zakiye; Pakzad, Reza; Kabir, Kourosh; Norouzi, Mehdi; Soleimani, Alireza; Yaghoobi, Mojtaba Hedayat; Shadabi, Shahrzad; Tajbakhsh, Ramin; Khairabad, Ali Kargar; Mozhgani, Sayed-Hamidreza

Objective The COVID-19 pandemic has called an urgent need for drug repurposing to improve the outcome of the disease. Quaternary ammonium compounds have been demonstrated to have antiviral effects and may be of use against SARS-CoV-2 infections. Design In this double-blind, single-center study, we enrolled patients with positive PCR test and/or CT findings for COVID-19. The participants of each group were randomly assigned to Diphenhydramine Compound (Diphenhydramine + Ammonium Chloride) plus standard of care or to Diphenhydramine alone and standard of care groups. The primary outcome was all-cause mortality within 30 days of randomization. Secondary outcomes include viral burden, clinical status, assessed by a 5-point ordinal scale, and length of stay in hospitalized patients. Results A total of 120 patients were included in the trial, 60 of which were assigned to Ammonium Chloride group. The primary endpoint was not statistically different between the two groups (HR: 3.02 (95% CI, 0.57-16.06; p = 0.195)). Recovery time and viral burden was significantly lower in Ammonium Chloride group corresponding to odds ratios of 1.8 (95% CI, 1.15-2.83; p = 0.01) and 7.90 (95% CI, 1.62-14.17; p = 0.014), respectively. Conclusion The findings of this advocates the careful addition of Ammonium Chloride to standard of care for COVID-19 patients.