Inspiratory muscle training for recovered COVID-19 patients after weaning from mechanical ventilation: A pilot control clinical study.

BACKGROUND: To the best of our knowledge, no studies have evaluated the effects of inspiratory muscle training (IMT) on recovered COVID-19 patients after weaning from mechanical ventilation. Therefore, this study assessed the efficacy of IMT on recovered COVID-19 patients following mechanical ventilation. METHODS: Forty-two recovered COVID-19 patients (33 men and 9 women) weaned from mechanical ventilation with a mean age of 48.05 ±â€Š8.85 years were enrolled in this pilot control clinical study. Twenty-one patients were equipped to 2-week IMT (IMT group) and 21 matched peers were recruited as a control (control group). Forced vital capacity (FVC%), forced expiratory volume in 1 second (FEV1%), dyspnea severity index (DSI), quality of life (QOL), and six-minute walk test (6-MWT) were assessed initially before starting the study intervention and immediately after intervention. RESULTS: Significant interaction effects were observed in the IMT when compared to control group, FVC% (F = 5.31, P = .041, ηP2 = 0.13), FEV1% (F = 4.91, P = .043, ηP2 = 0.12), DSI (F = 4.56, P = .032, ηP2 = 0.15), QOL (F = 6.14, P = .021, ηP2 = 0.17), and 6-MWT (F = 9.34, P = .028, ηP2 = 0.16). Within-group analysis showed a significant improvement in the IMT group (FVC%, P = .047, FEV1%, P = .039, DSI, P = .001, QOL, P < .001, and 6-MWT, P < .001), whereas the control group displayed nonsignificant changes (P > .05). CONCLUSIONS: A 2-week IMT improves pulmonary functions, dyspnea, functional performance, and QOL in recovered intensive care unit (ICU) COVID-19 patients after consecutive weaning from mechanical ventilation. IMT program should be encouraged in the COVID-19 management protocol, specifically with ICU patients.

Safety and Efficacy of Convalescent Plasma for Severe COVID-19: Interim Report of a Multicenter Phase II Study from Saudi Arabia.

OBJECTIVE: To present the interim findings from a national study investigating the safety and efficacy of convalescent plasma (CP) containing detectable IgG antibodies as a treatment strategy for severe coronavirus disease 2019 (COVID-19). TRIAL DESIGN AND PARTICIPANTS: An open label, two-arm, phase-II clinical trial conducted across 22 hospitals from Saudi Arabia. The intervention group included 40 adults (aged ≥18 years) with confirmed severe COVID-19 and the control group included 124 patients matched using propensity score for age, gender, intubation status, and history of diabetes and/or hypertension. Intervention group included those (a) with severe symptoms (dyspnea; respiratory rate, ≥30/min; SpO2, ≤93%, PaO2/FiO2 ratio, <300; and/or lung infiltrates >50% within 24-48 h), (b) requiring intensive care unit (ICU) care or (c) experiencing life-threatening conditions. The control group included confirmed severe COVID-19 patients of similar characteristics who did not consent for CP infusion or were not able to receive CP due to its nonavailability. INTERVENTIONS: The intervention group participants were infused 300 ml (200-400 ml/treatment dose) CP at least once, and if required, daily for up to 5 sessions, along with receiving the best standard of care. The control group only received the best standard of care. OUTCOMES: The primary endpoints were safety and ICU length of stay (LOS). The secondary endpoints included 30-day mortality, days on mechanical ventilation and days to clinical recovery. RESULTS: CP transfusion did not result in any adverse effects. There was no difference in the ICU LOS (median 8 days in both groups). The mortality risk was lower in the CP group: 13% absolute risk reduction (P = 0.147), hazard ratio (95% confidence interval): 0.554 (0.299-1.027; P = 0.061) by log-rank test. There was no significant difference in the days on mechanical ventilation and days to clinical recovery. CONCLUSION: CP containing detectable antibodies is a safe strategy and may result in a decrease in mortality in patients with severe COVID-19. The results of the completed trial with a larger study sample would provide more clarity if this difference in mortality is significant. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04347681; Saudi Clinical Trials Registry No.: 20041102.