Covid-19
RCT: Lack of significant effect of Paxlovid (nirmatrelvir–ritonavir) on symptom alleviation in Covid-19
26 Apr, 2024 | 11:49h | UTCStudy Design and Population:
This phase 2–3 randomized clinical trial investigated the efficacy of nirmatrelvir in combination with ritonavir for treating mild-to-moderate Covid-19 in adults. Participants, both vaccinated and unvaccinated, were enrolled based on their risk factors for severe Covid-19. The study included 1296 adults who had confirmed Covid-19 with symptom onset within the past 5 days. They were randomly assigned to receive either nirmatrelvir–ritonavir or placebo every 12 hours for 5 days.
Main Findings:
The primary endpoint was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Results showed that the median time to alleviation was 12 days for the treatment group and 13 days for the placebo group, a difference that was not statistically significant (P=0.60). Hospitalizations and deaths were slightly lower in the treatment group (0.8%) compared to the placebo group (1.6%), but this difference was also not statistically significant. Adverse events were similar across both groups, with dysgeusia and diarrhea being the most common in the treatment group.
Implications for Practice:
The findings indicate that nirmatrelvir–ritonavir treatment does not significantly reduce the time to symptom alleviation for Covid-19 compared to placebo among vaccinated or unvaccinated adults. These results suggest that further research is needed to explore the potential benefits of this treatment in specific subpopulations or in combination with other interventions.
Reference (free full-text):
RCT: Lower oxygenation target improves days alive without life support in severe COVID-19 hypoxemia
21 Mar, 2024 | 13:46h | UTCStudy Design and Population: This multicenter randomized clinical trial investigated the impact of different oxygenation targets on the survival of adult patients with COVID-19 and severe hypoxemia in the ICU. Conducted across 11 European ICUs from August 2020 to March 2023, the study involved 726 patients requiring at least 10 L/min of oxygen or mechanical ventilation. Participants were randomly assigned to receive an oxygenation target of either 60 mm Hg (lower oxygenation group, n=365) or 90 mm Hg (higher oxygenation group, n=361) for up to 90 days.
Main Findings: The primary outcome was the number of days alive without life support at 90 days post-intervention. Patients in the lower oxygenation group achieved a median of 80.0 days alive without life support compared to 72.0 days in the higher oxygenation group, a difference that was statistically significant (P=0.009). Although there was a slight reduction in mortality at 90 days in the lower oxygenation group (30.2% vs 34.7% in the higher group), this was not statistically significant. No significant differences were observed in the proportion of patients with serious adverse events or the number of days alive and out of hospital.
Implications for Practice: Targeting a lower Pao2 of 60 mm Hg in ICU patients with COVID-19 and severe hypoxemia appears to increase the days alive without life support compared to a higher target of 90 mm Hg, without increasing serious adverse events. This finding suggests that a lower oxygenation target could be more beneficial for this patient population, potentially guiding clinical practice in managing oxygen therapy for severe COVID-19 cases.
Reference
Reference: Nielsen FM et al. (2024). Randomized Clinical Trial: Effect of Oxygenation Targets on Survival Without Life Support in COVID-19 Patients with Severe Hypoxemia. JAMA, Published online March 19, 2024. DOI: 10.1001/jama.2024.2934. Access the study here: [Link]
Multinational Study | No correlation between Covid-19 and onset of type 1 diabetes in children
8 Aug, 2023 | 13:32h | UTC
Opinion | Bad science needs to be called out: the medical profession loses trust when bad studies are used to promote policy
1 Aug, 2023 | 14:29h | UTCBad Science Needs to Be Called Out – Sensible Medicine
Related: Did Republicans die more during the pandemic bc they didn’t get the vax? – By Dr. Vinay Prassad
Original Study: Excess Death Rates for Republican and Democratic Registered Voters in Florida and Ohio During the COVID-19 Pandemic – JAMA Internal Medicine
Critical Appraisal | Did Republicans die more during the pandemic bc they didn’t get the vax?
1 Aug, 2023 | 14:28h | UTCDid Republicans die more during the pandemic bc they didn’t get the vax? – By Dr. Vinay Prassad
Related: Bad Science Needs to Be Called Out – Sensible Medicine
Original Study: Excess Death Rates for Republican and Democratic Registered Voters in Florida and Ohio During the COVID-19 Pandemic – JAMA Internal Medicine
Opinion Video | Critical analysis of the data behind Covid-19 booster shots
31 Jul, 2023 | 14:40h | UTCOriginal Publication: Correspondence | Potential “healthy vaccinee bias” in a study of BNT162b2 vaccine against Covid-19
Mitigating neurological, cognitive, and psychiatric sequelae of COVID-19-related critical illness
26 Jul, 2023 | 13:28h | UTC
Correspondence | Potential “healthy vaccinee bias” in a study of BNT162b2 vaccine against Covid-19
21 Jul, 2023 | 13:43h | UTC
Commentary from the author on Twitter (thread – click for more)
Our correspondence is out in @njem written w @VPrasadMDMPH & Ram Duriseti
We show v strong evidence of healthy vaccinee bias in an Israeli study of Pfizer booster vs covid death, which wasn't disclosed
Could explain ALL reported benefit of the booster?https://t.co/F3WeafvUnw pic.twitter.com/b29YQ0lblh
— Tracy Høeg, MD, PhD (@TracyBethHoeg) July 20, 2023
Review | Post-COVID Conditions
7 Jul, 2023 | 16:21h | UTCPost-COVID Conditions – Mayo Clinic Proceedings
Consensus Statement 2023 Update | Timing of elective surgery and risk assessment after SARS-CoV-2 infection
30 Jun, 2023 | 15:00h | UTCTiming of elective surgery and risk assessment after SARS-CoV-2 infection: 2023 update – Anaesthesia
Commentary on Twitter
?"In most circumstances, surgery should proceed unless risk assessment indicates that the risk of proceeding exceeds the risk of delay."@Assoc_Anaes @RCoANews @UkFssa @RCSnews @elboghdadly @doctimcook @justin_kua @NigelMercer @rmoonesinghe
?https://t.co/gfjymze0oi pic.twitter.com/D8bEfAHBD7
— ??????????? (@Anaes_Journal) June 20, 2023
Review | Breathing difficulties after covid-19: a guide for primary care
29 Jun, 2023 | 14:04h | UTCBreathing difficulties after covid-19: a guide for primary care – The BMJ
Opinion | Strategic masking to protect patients from all respiratory viral infections
20 Jun, 2023 | 12:50h | UTCStrategic Masking to Protect Patients from All Respiratory Viral Infections – New England Journal of Medicine (link to abstract – $ for full-text)
Perspective | Observational studies must be reformed before the next pandemic
15 Jun, 2023 | 15:12h | UTCObservational studies must be reformed before the next pandemic – Nature Medicine
Review | Wastewater monitoring can anchor global disease surveillance systems
13 Jun, 2023 | 14:07h | UTCWastewater monitoring can anchor global disease surveillance systems – The Lancet Global Health
Related:
Use of Wastewater for Mpox Outbreak Surveillance in California – New England Journal of Medicine
Opinion: Wastewater analysis can be a powerful public health tool—if it’s done sensibly.
CDC unveils its latest weapon in Covid-19 detection: wastewater.
[Preprint] Wastewater genomic testing can effectively track COVID-19 variants of concern.
Human Waste Could Be The Next Big Weapon in Controlling COVID-19 – TIME
Next steps for wastewater testing to help end this pandemic — and prevent the next one – STAT
The myriad ways sewage surveillance is helping fight COVID around the world – Nature
It’s time to begin a national wastewater testing program for Covid-19 – STAT
Coronavirus: Testing sewage an ‘easy win’ – BBC
2ry Analysis of a RCT | Metformin linked to 41% reduction in long COVID incidence in outpatient treatment
12 Jun, 2023 | 13:55h | UTCNews Release: Study shows metformin lowers the risk of getting long COVID – University of Minnesota Medical School
Commentary on Twitter
These data not persuasive. There are 6 different arms. 3 drugs. This is not the primary endpoint. No adjustment for multiple testing.
Even USFDA would not accept these data for regulatory approval, and they are basically working for Pharma at this pthttps://t.co/FZoxo9shtG
— Vinay Prasad MD MPH (@VPrasadMDMPH) June 9, 2023
RCT | P2Y12 inhibitors don’t improve outcomes in critically ill COVID-19 patients
31 May, 2023 | 14:13h | UTCSee also: Visual Abstract
RCT | Rivaroxaban doesn’t reduce thrombotic events, hospitalization, or death in outpatients with COVID-19
15 May, 2023 | 13:19h | UTCSummary: The PREVENT-HD trial, a double-blind, placebo-controlled randomized study, was conducted to evaluate the effectiveness of prophylactic anticoagulation in reducing venous and arterial thrombosis, hospitalization, and death in nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor. The trial took place between August 2020 and April 2022 across 14 US integrated healthcare delivery networks, with 1,284 patients enrolled and randomly assigned to receive either 10 mg of oral rivaroxaban or placebo daily for 35 days.
However, the study was terminated prematurely due to enrollment challenges and lower-than-expected event rates. The primary efficacy outcome, a composite of various hazardous events, occurred in 3.4% of the rivaroxaban group and 3.0% of the placebo group, with no significant difference between the two groups (hazard ratio, 1.16 [95% CI, 0.63–2.15]; P=0.63). No critical-site or fatal bleeding was observed, and only one patient in the rivaroxaban group experienced a major bleed.
In conclusion, rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis does not appear to reduce the composite end point of venous and arterial thrombotic events, hospitalization, and death. The study’s premature termination and lower-than-expected event rates may limit the generalizability of these findings.
Commentary on Twitter
#OriginalArticle: In this #RCT, Rivaroxaban did not appear to reduce a composite endpoint of venous and arterial thrombotic events, hospitalization, and death among non‐hospitalized patients with symptomatic COVID‐19 #AHAJournals https://t.co/PhdXnTJ0V9 pic.twitter.com/f04uYu2M5f
— Circulation (@CircAHA) May 10, 2023
RCT | Cognitive behavioral therapy proves effective for severe post-COVID-19 fatigue
15 May, 2023 | 13:16h | UTCNews Release: Cognitive behavioral therapy lessens post-viral fatigue after COVID-19 – Amsterdam UMC
Commentary on Twitter
Efficacy of Cognitive Behavioral Therapy Targeting Severe Fatigue Following COVID-19: Results of a Randomized Controlled Trial
✅ Just Accepted
? Open Access@amsterdamUMChttps://t.co/P1jwLOcfvw— Clinical Infectious Diseases (@CIDJournal) May 13, 2023
M-A | Association of SARS-CoV-2 vaccination or infection with Bell palsy
10 May, 2023 | 16:03h | UTC
Review | Therapeutics for COVID-19
9 May, 2023 | 14:53h | UTCTherapeutics for COVID-19 – Nature Microbiology
Commentary on Twitter
?New Perspective out now:
Therapeutics for COVID-19
By Sima Toussi, Jennifer Hammond, Brian Gerstenberger & Annaliesa Andersonhttps://t.co/WNJzkFMFuF
— Nature Microbiology (@NatureMicrobiol) May 5, 2023
Cohort Study | Limited evidence linking COVID-19 vaccines to menstrual disturbance or postmenopausal bleeding
9 May, 2023 | 14:52h | UTCNews Release: New study finds no increased risk of menstrual changes after covid-19 vaccination – BMJ Newsroom
Commentary: Large study shows no changes to menstrual cycles after COVID vaccination – CIDRAP
Related:
Editorial: Menstruation and Covid-19 vaccination.
Commentary on Twitter
The findings of this new study do not provide substantial support for a causal association between SARS-CoV-2 vaccination and healthcare contacts related to menstrual or bleeding disordershttps://t.co/Tsw2hjIiIz
— The BMJ (@bmj_latest) May 4, 2023
WHO declares end to COVID-19 global health emergency
8 May, 2023 | 13:26h | UTCWHO Declares End to COVID-19 Global Health Emergency – Health Policy Watch
RCT | BCG vaccine did not protect health care workers against Covid-19
4 May, 2023 | 13:56h | UTCCommentary: The BCG vaccine does not decrease the risk of COVID-19 in healthcare workers – News Medical
Commentary on Twitter
The bacille Calmette–Guérin vaccine may enhance generic antiviral immunity. In a randomized, controlled trial, health care workers received BCG vaccination or placebo. The BCG vaccine did not reduce Covid-19 risk. https://t.co/f2Uu4yhYZP
— NEJM (@NEJM) April 26, 2023
RCT | Oral fluvoxamine plus inhaled budesonide reduced hospitalizations in high-risk patients with early-onset COVID-19
24 Apr, 2023 | 13:51h | UTC
Commentary on Twitter
Treatment w/ oral fluvoxamine + inhaled budesonide among high-risk outpatients w/ early #COVID19 reduced incidence of severe disease requiring advanced care. The combined effect seems to offer benefits over individual use of each drug: https://t.co/wM2da5a5MD pic.twitter.com/Sl1qFzTOjD
— Annals of Int Med (@AnnalsofIM) April 19, 2023
RCT | Higher dose corticosteroids increase mortality in hypoxic COVID-19 patients on simple oxygen
24 Apr, 2023 | 13:55h | UTCEditorial: Higher-dose dexamethasone for patients with COVID-19 and hypoxaemia? – The Lancet
Commentary: Higher-dose corticosteroids tied to 60% more deaths in low-oxygen COVID patients – CIDRAP
Commentary on Twitter (thread – click for more)
Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support.
A new study evaluated the use of a higher dose of corticosteroids in this patient group. https://t.co/uJGSYSBQAO
— The Lancet (@TheLancet) April 13, 2023