risk management

COVID-19 Roundup: Sotrovimab Treatment, Myocardial Sequelae, Postpartum Depression, Multiple Sclerosis Outcomes

Effect of Early Sotrovimab Treatment1

In an international, multicenter, randomized clinical trial, a single IV dose of the neutralizing antibody sotrovimab significantly reduced the proportion of participants who experienced all-cause death or hospitalization for more than 24 hours through day 29 compared with placebo (1% vs 6%, respectively; relative risk, 0.21). The trial was done in 1057 participants with symptomatic, mild to moderate COVID‑19 who were at risk of disease progression.

Adverse events reported during the trial were infrequent and similar for both study groups. The most common adverse event in those who received sotrovimab was diarrhea in 2% of participants (n = 8).

“Findings support sotrovimab as a treatment option for non-hospitalized, high-risk patients with mild to moderate COVID-19,” researchers concluded.

Whether sotrovimab is effective against SARS-CoV-2 variants that have emerged since the study was completed in March of 2021 is unknown.

Managing Myocardial Sequelae2

The American College of Cardiology released an expert consensus solution set to provide practical recommendations on the diagnosis and management of myocarditis and other post-acute sequelae of SARS-CoV-2 infection in adult patients with chest pain, shortness of breath, palpitations, and fainting after SARS-CoV-2 infection. This document also covers determining whether or when to recommend that affected adult athletes should return to playing sports.

Among the recommendations:

  • For patients with an increased suspicion of cardiac involvement with COVID-19, an electrocardiogram, measurement of cardiac troponin (preferably with a high-sensitivity assay), and an echocardiogram should be conducted.
  • For patients with myocarditis, guideline-directed medical therapy for heart failure should be followed as appropriate.
  • For patients with post-acute sequelae of SARS-CoV-2, recumbent or semi-recumbent exercise is recommended with gradual increases and transition to upright exercise as functional capacity and orthostatic intolerance improves.
  • For athletes recovering from COVID-19 with ongoing cardiopulmonary symptoms, triad testing should be performed. Athletes with myocarditis should discontinue exercise for 3 to 6 months.

Postpartum Depression Increased During the Pandemic3

Of a 670-participant sample of US postpartum patients recruited through social media who delivered a live infant during the early phase of the COVID-19 public health emergency, 38% were clinically depressed as reflected in their Edinburgh Postnatal Depression Scale score.  Prior to the pandemic, the rate of postpartum depression in the United States was 7% to 13%. This cross-sectional survey study was completed between February 2020 and July 2020.

Moreover, 22% of the study sample were found to have major depressive symptoms, and each 1‑week increase in time elapsed postpartum increased the chances of having depression by 4%.

Participants who worried that they themselves or their infant might contract COVID-19 were 71% more likely to have postpartum depression than those who did not worry, and participants whose infants were admitted to a neonatal intensive care unit (NICU) were 74% more likely to have postpartum depression than those whose infants were not admitted to the NICU.

Compared with participants who breast fed their infants or bottle fed them with their own milk, participants with formula-fed infants had a 92% greater chance of having postpartum depression and were 73% more likely to have major depressive symptoms.

COVID-19 Outcomes in Patients with Multiple Sclerosis4

Individuals with relapsing multiple sclerosis (RMS) and COVID-19 who were treated with ofatumumab, a B-cell-depleting therapy, had COVID-19 cases that were mostly mild (44%) or moderate (46%) in severity and not serious, according to an analysis of an ongoing, open-label, phase 3b study. Of the 1703 participants with observational data collected from December 2019 onward, 245 participants reported COVID-19 infections.  

Nevertheless, 24 participants who received ofatumumab experienced severe or life-threatening COVID-19 (9.8%), and 2 died. Ofatumumab was temporarily interrupted in 39 participants with COVID-19, or 15.9%. Seven of the 476 participants who were fully vaccinated against COVID‑19 (1.5%) contracted COVID-19.

Another 90 patients with RMS who received ofatumumab during the post-marketing period (August 2020 through late September 2021) were confirmed to have contracted COVID-19; 80 of these cases were non-serious, 10 were serious, and 9 required hospital admission, but no deaths occurred.

“COVID-19 in RMS patients on ofatumumab was primarily of mild/moderate severity and non-serious in these observational data,” the researchers concluded. “Most recovered from COVID-19 without treatment interruption....Breakthrough COVID-19 despite being fully/partially vaccinated was uncommon.”

 

—Ellen Kurek

 

References:

1. Gupta A, Gonzalez-Rojas Y, Juarez E, et al. Effect of sotrovimab on hospitalization or death among high-risk patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. Published online March 14, 2022. Accessed March 20, 2022. doi:10.1001/jama.2022.2832

2. Gluckman TJ, Bhave NM, Allen LA, et al. 2022 ACC Expert Consensus Decision Pathway on cardiovascular sequelae of COVID-19 in adults: myocarditis and other myocardial involvement, post-acute sequelae of SARS-CoV-2 infection, and return to play: a report of the American College of Cardiology Solution Set Oversight Committee. JACC. 2022. Published online March 16, 2022. Accessed March 20, 2022. doi:10.1016/j.jacc.2022.02.003

3. Shuman CJ, Peahl AF, Pareddy N, Morgan ME, Chiangong J, Veliz PT, Dalton VK. Postpartum depression and associated risk factors during the COVID-19 pandemic. BMC Research Notes. 2022;15:102-106. Published online March 14, 2022. Accessed March 20, 2022. doi:10.1186/s13104-022-05991-8

4. Cross AH, Delgado S, Habek M, et al. COVID-19 outcomes and vaccination in people with relapsing multiple sclerosis treated with ofatumumab. Neurol Ther. Published online March 13, 2022. Accessed March 20, 2022. doi:10.1007/s40120-022-00341-z