Coronavirus disease 2019 (COVID-19) is a disease of the airway caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, on 30 June  2021, there were 182,629,207 confirmed cases of COVID-19, globally including 3,954,936 deaths, and in Kenya, 183,608 confirmed cases including  3,621 deaths as reported by World Health Organization (WHO).While most cases are mild or asymptomatic, the disease that has worsened can result in hospitalization, requirement for assisted breathing, and even death. COVID-19 is estimated to be about 10 times more deadly than seasonal flu caused by influenza virus. The risk factors for an unfavorable course include advancing age, obesity, and comorbidities such as diabetes mellitus and hypertension. Weeks and months after the onset of COVID-19 some infected patients still continue to suffer from symptoms also called Long-COVID-19 or Post-COVID-19 syndrome. This seems to affect patients with mild COVID-19 as well as those with moderate-to-severe disease. The scale of the pandemic makes the prevention of Long-COVID-syndrome an imperative. It is thought that by managing the infection earlier, post viral syndromes could be reduced in incidence and severity. Though several vaccines against COVID-19 have become available for use, and vaccinations have been initiated in many countries for the most vulnerable and the most exposed population, the limited availability of vaccines in many middle- or low-income countries, is anticipated to remain a bottleneck well beyond 2021, and herd immunity is unlikely before 2023. Hence the need for drugs that can be used early during the course of infection to prevent disease progression and longer-term complications.

This is a multicenter study designed to use Novaferon in treatment of ambulatory adult patients with symptomatic COVID-19. The study aims to analyse the safety and efficacy of the drug, Novaferon, in adult patients with symptomatic COVID-19. The study is composed of two Cohorts: A and B. In Cohort A, 40 patients will receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC to confirm that Novaferon is well-tolerated in a small population prior to Cohort B. For Cohort A, the primary outcome is to see how Novaferon is safe and well-tolerated in patients. Cohort B is the main portion of the study. In this cohort, up to 874 patients will receive either Novaferon or placebo via a commercial nebulizer, plus SOC. For Cohort B, the primary outcome is to analyse the rate of clinical deterioration in patients as of Day 28.

 The overall purpose of the study is to establish the safety and efficacy of aerolized Novaferon in moderate to severe and mild to moderate Covid-19. Participants will be followed up for 2 months. 

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by the novel severe acute

respiratory syndrome coronavirus 2 (SARS-CoV-2). During the current SARS-CoV-2 outbreak, the incidence of known cases has rapidly increased such that, on 30 June  2021, there were 182,629,207 confirmed cases of COVID-19, globally including 3,954,936 deaths, and in Kenya, 183,608 confirmed cases including  3,621 deaths as reported by World Health Organization (WHO). While most cases are mild or asymptomatic, progressive disease can result in hospitalization, requirement for mechanical ventilation, and substantial morbidity and mortality. SARS-CoV-2 is estimated to be about 10 times more deadly than seasonal influenza virus. Risk factors for an unfavorable course include advancing age, obesity, and comorbidities such as diabetes mellitus and hypertension. Weeks and months after the onset of acute COVID-19 some infected patients still continue to suffer from symptoms also called Long-COVID-19 or Post-COVID-19 syndrome. This seems to affect patients with mild COVID-19 as well as those with moderate-to-severe disease. The scale of the pandemic makes the prevention of Long-COVID-syndrome an imperative. It has been hypothesized that by managing the infection earlier post viral syndromes (including Long-COVID-syndrome) could be reduced in incidence and severity. Though several vaccines against SARS-CoV-2 have become available for use, and vaccinations have been initiated in many countries for the most vulnerable and the most exposed population, the limited availability of vaccines in many middle- or low-income countries, is anticipated to remain a bottleneck well beyond 2021, and herd immunity is unlikely before 2023. Interventions that can be administered early during the course of infection to prevent disease progression and longer-term complications are urgently needed.

This is a randomized, double-blind, placebo-controlled, multicenter study of to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon in ambulatory adult patients with symptomatic COVID-19. The study is composed of two Cohorts: A and B. In Cohort A, 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC to confirm that Novaferon is well-tolerated in target population prior to initiating Cohort B. For Cohort A, the primary outcome is the safety and tolerability of Novaferon treatment as assessed by AEs. Preliminary assessments of clinical efficacy will also be performed. Cohort B is the main portion of the study. This cohort  comprises two  treatment groups. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC. For Cohort B, the primary outcome is the rate of clinical deterioration as of Day 28.