ABSTRACT
OBJECTIVE: The COVID-19 pandemic is progressing rapidly, sending the world into a great panic. Healthcare professionals have responded by embarking on a concerted search for therapies to cure and prevent COVID-19. Recently, interferon (IFN) has emerged as a potential therapy as it is associated with reducing lung inflammation and suppressing viral replication. This research paper assessed the efficacy of high-dose nebulized IFN α 2b in severe COVID-19 pneumonia. METHODS: This is a retrospective study. It commenced on April 9 and ended on June 17, 2020. Researchers selected participants from hospitalized patients aged 18 years and above who were diagnosed with severe COVID-19 pneumonia. Other inclusion criteria were bilateral pneumonia on lung or chest X-ray scan and severe respiratory distress. SMART-COP, which is a risk stratification scoring tool, and radiologic severity index (RSI) were used to assess pneumonia severity. Patients in the treatment cohort received nebulized IFN α 2b at a dose of 10 million IU every 12 hours for 5 days, in addition to standard treatment. Patients in the control cohort received standard treatment only. RESULTS: Seventy-three patients met the inclusion criteria; 37 were included in the treatment cohort and 36 in the control cohort. Mechanical ventilation was needed in 14 of 36 (38.9%) patients in the control cohort, compared with 6 of 37 (27.4%) patients in the treatment cohort (HR 5.62 [95% CI 1.81-17.48]; P = .003). For pneumonia severity, there was a hazard ratio (HR) of 3.72 [95% CI 1.74- 7.98]; P = ·.01. After 5 days of treatment, chest X-rays indicated significant beneficial changes in the treatment group (HR 2.24 [CI 1.05-4.79]; P = .036). Multivariate analysis revealed that pneumonia severity and RSI remained higher in the control group. The HR was 3.44 [95% CI 1.49-7.94]; P = .004 and 2.26 [95% CI 0.99-5.16]; P = .05, respectively. There was an increase in liver aminotransferases in 5 (14%) participants in the control cohort and 3 (8%) participants in the treatment cohort. CONCLUSION: High-dose nebulized IFN α 2b has potential efficacy in mitigating severe COVID-19 pneumonia. This study established that administering high-dose nebulized IFN α 2b significantly reduces pneumonia severity in COVID-19 patients. We also found a strong relationship between using nebulized IFN α 2b and reduced need for mechanical ventilation among patients with severe COVID-19 pneumonia. However, a well-designed control trial is needed to confirm the drug's efficacy in reducing the COVID-19 pneumonia severity.
ABSTRACT
Importance: Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed. Objective: To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines. Design, Setting, and Participants: Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19. Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively. Interventions: Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 µg/dose; n = 13 459) and HB02 (4 µg/dose; n = 13 465) strains or an aluminum hydroxide (alum)-only control (n = 13 458); they received 2 intramuscular injections 21 days apart. Main Outcomes and Measures: The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose. Results: Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum-only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase-polymerase chain reaction test results at enrollment were included in the primary efficacy analysis. During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%-86.3%) for HB02 (P < .001 for both). Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]). Conclusions and Relevance: In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending. Trial Registration: ClinicalTrials.gov Identifier: NCT04510207; Chinese Clinical Trial Registry: ChiCTR2000034780.