Effects of Lianhuaqingwen Capsules in adults with mild-to-moderate coronavirus disease 2019: an international, multicenter, double-blind, randomized controlled trial.

BACKGROUND: In a randomized trial, Lianhuaqingwen (LHQW) capsule was effective for accelerating symptom recovery among patients with coronavirus disease 2019 (COVID-19). However, the lack of blinding and limited sample sizes decreased the level of clinical evidence. OBJECTIVES: To evaluate the efficacy and safety of LHQW capsule in adults with mild-to-moderate COVID-19. METHODS: We conducted a double-blind randomized controlled trial in adults with mild-to-moderate COVID-19 (17 sites from China, Thailand, Philippine and Vietnam). Patients received standard-of-care alone or plus LHQW capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the median time to sustained clinical improvement or resolution of nine major symptoms. RESULTS: The full-analysis set consisted of 410 patients in LHQW capsules and 405 in placebo group. LHQW significantly shortened the primary endpoint in the full-analysis set (4.0 vs. 6.7 days, hazards ratio: 1.63, 95% confidence interval: 1.39-1.90). LHQW capsules shortened the median time to sustained clinical improvement or resolution of stuffy or runny nose (2.8 vs. 3.7 days), sore throat (2.0 vs. 2.6 days), cough (3.2 vs. 4.9 days), feeling hot or feverish (1.0 vs. 1.3 days), low energy or tiredness (1.3 vs. 1.9 days), and myalgia (1.5 vs. 2.0 days). The duration to sustained clinical improvement or resolution of shortness of breath, headache, and chills or shivering did not differ significantly between the two groups. Safety was comparable between the two groups. No serious adverse events were reported. INTERPRETATION: LHQW capsules promote recovery of mild-to-moderate COVID-19 via accelerating symptom resolution and were well tolerated. Trial registration ChiCTR2200056727 .

Effect of Nighttime Earplugs and Eye Masks on Sleep Quality in Intensive Care Unit Patients.

PURPOSE: Poor sleep quality in intensive care unit (ICU) can be associated with poor outcome. Excessive noise and lights in ICU are known to disrupt patients' sleep by causing arousals. STUDY DESIGN: A prospective randomized controlled study. MATERIALS AND METHODS: The patients admitted to the medical ICU were prospectively included and randomized to receive earplugs and eye masks or no intervention during their first 5 nights in ICU. Their arousal index and other sleep parameters were measured during the first night by polysomnography. Secondary outcomes including wrist actigraphy profiles and subjective sleep quality were recorded during all study nights. RESULTS: Seventeen patients were enrolled. Eight patients were randomized to earplugs and eye masks group and nine patients were randomized to control group during their first 5 nights in the ICU. The use of earplugs and eye masks demonstrated the trend toward lower arousal index during the first night (21.15 (14.60) vs 42.10 (18.20) events per hour, p = 0.086) and increased activity index (activity count/hour) (16.12 (7.99) vs 10.84 (10.39) count/hour, p = 0.059) compared to control group. Polysomnography and actigraphy did not demonstrate good agreement. CONCLUSION: The use of earplugs and eye masks has a trend toward reduction in arousal index and increased activity in patients admitted to ICU. Limited sample size most likely explained insignificant difference in outcomes. Wrist actigraphy did not accurately measure sleep parameters in ICU patients. TRIAL REGISTRATION: www.clinicaltrials.in.th, TCTR20170727003. HOW TO CITE THIS ARTICLE: Arttawejkul P, Reutrakul S, Muntham D, Chirakalwasan N. Effect of Nighttime Earplugs and Eye Masks on Sleep Quality in Intensive Care Unit Patients. Indian J Crit Care Med 2020;24(1):6-10.

Favipiravir treatment in non-severe COVID-19: promising results from multicenter propensity score-matched study (FAVICOV).

This study aimed to evaluate the efficacy of favipiravir (FPV) in preventing the development of severe COVID-19 in patients with mild-to-moderate symptoms. The study evaluated 1037 COVID-19 patients treated with FPV or standard treatment between April and September 2021, analyzed by propensity score matching. 149 patients were included in each arm after propensity score matching. The clinical outcomes showed no deterioration of the WHO clinical progression scale in the FPV group compared to the standard treatment group on day 5 (83.2% vs. 69.1%, p < 0.001). The WHO clinical progression scale also showed improvements on day 14 in the FPV group compared to the standard treatment group (66.4% vs. 46.3%, p < 0.001). The rates of oxygen supplementation and hospitalization were significantly lower in the FPV group compared to the standard treatment group (0% vs. 12.1% and 0.7% vs. 17.4%, respectively, p < 0.001 for both). There were no differences in adverse events between the two groups. The study highlights the effectiveness of FPV in preventing severe COVID-19 and hospitalization in patients with mild-to-moderate symptoms. The findings emphasize the importance of personalized treatment plans for COVID-19 patients, starting FPV treatment early, and adjusting dosages based on ethnicity and body weight.

Efficacy and safety of Lianhua Qingwen capsules combined with standard of care in the treatment of adult patients with mild to moderate COVID-19 (FLOSAN): protocol for a randomized, double-blind, international multicenter clinical trial.

Background: Effective anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) drugs are not only the next defense after vaccines but also the key part of establishing a multi-tiered coronavirus disease 2019 (COVID-19) prevention and control system. Previous studies had indicated that Lianhua Qingwen (LHQW) capsules could be an efficacious Chinese patent drug for treating mild to moderate COVID-19. However, pharmacoeconomic evaluations are lacking, and few trials have been conducted in other countries or regions to evaluate the efficacy and safety of LHQW treatment. So, this study aims to explore the clinical efficacy, safety, and economy of LHQW for treating adult patients with mild to moderate COVID-19. Methods: This is a randomized, double-blind, placebo-controlled, international multicenter clinical trial protocol. A total of 860 eligible subjects are randomized at a 1:1 ratio into the LHQW or placebo group to receive two-week treatment and follow-up visits on days 0, 3, 7, 10, and 14. Clinical symptoms, patient compliance, adverse effects, cost scale, and other indicators are recorded. The primary outcomes will be the measured median time to sustained improvement or resolution of the nine major symptoms during the 14-day observation period. Secondary outcomes regarding clinical efficacy will be evaluated in detail on the basis of clinical symptoms (especially body temperature, gastrointestinal symptoms, smell loss, and taste loss), viral nucleic acid, imaging (CT/chest X-ray), the incidence of severe/critical illness, mortality, and inflammatory factors. Moreover, we will assess health care cost, health utility, and incremental cost-effectiveness ratio (ICER) for economic evaluation. Discussion: This is the first international multicenter randomized controlled trial (RCT) of Chinese patent medicine for the treatment of early COVID-19 in accordance with WHO guidelines on COVID-19 management. This study will help clarify the potential efficacy and cost-effectiveness of LHQW in the treatment of mild to moderate COVID-19, facilitating decision-making by healthcare workers. Registration: This study is registered at the Chinese Clinical Trial Registry, with registration number: ChiCTR2200056727 (date of first registration: 11/02/2022).

A case of pulmonary infection caused by Mycobacterium asiaticum: Difficulties on diagnostic and therapeutic approaches.

A 56-year-old previously healthy female presented with chronic productive cough and fever. Chest X-ray revealed right middle lung opacities. Sputum acid fast bacilli smear was positive, however polymerase chain reaction was negative for Mycobacterium tuberculosis. Further investigations were pursued, which identified Mycobacterium asiaticum. Appropriate therapy with isoniazid, rifampin and clarithromycin for total 18 months (including pyrazinamide and ethambutol for first 4 months) resulted in clinical and radiographic improvement. Recognition of the possibility of this rarely described pulmonary pathogen is essential for successful treatment.