Protectors from hospitalisation, the story so far.
Oral meds than can be prescribed from home with onset of symptoms
Molnupiravir, approved by MHRA
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The antiviral was found to be safe and effective following a stringent review of the available evidence.
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Public domain data, Merck press release
$ 700 per 5-day course
Under 50% reduction in deuteriation
Effect of early treatment with fluvoxamine
Together Trial group
Public domain data, Peer reviewed trial in the Lancet
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Adults with a risk factor
$4 for a 10-day course
32% protection against hospitalization
32% protection against death
Fluvoxamine is approved by the Food and Drug Administration as an antidepressant
Doctors already can prescribe it off-label — using their clinical judgment
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Ivermectin, Together trial results not yet released
PFIZER’S NOVEL COVID-19 ORAL ANTIVIRAL TREATMENT CANDIDATE REDUCED RISK OF HOSPITALIZATION OR DEATH BY 89% IN INTERIM ANALYSIS OF PHASE 2/3 EPIC-HR STUDY
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Public domain data, Pfizer press release
PAXLOVID™ (PF-07321332; ritonavir)
Found to reduce the risk of hospitalization or death by 89%
Compared to placebo in non-hospitalized high-risk adults with COVID-19
Through Day 28
PAXLOVID group
No deaths
Placebo group
10 deaths
Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible
Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients)
Randomized, double-blind study of non-hospitalized adult patients with COVID-19,
who are at high risk of progressing to severe illness
Scheduled interim analysis
89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo
In patients treated within 3 days of symptom onset
PAXLOVID group
0.8% of patients hospitalized
3/389 hospitalized with no deaths
Placebo group
7.0% of patients hospitalized or died
27/385 hospitalized
with 7 subsequent deaths
(p less than 0.0001) 1 in 10,000 chance
In patients treated within 5 days of symptom onset
PAXLOVID group
1.0% of patients hospitalized
6/607 hospitalized with no deaths
Placebo group
6. 7% of patients hospitalized or died
41/612 hospitalized,
with 10 subsequent deaths
p less than 0.0001
At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study
due to the overwhelming efficacy demonstrated in these results
About the Phase 2/3 EPIC-HR Study Interim Analysis
1,219 adults enrolled out of 3,000 planned
North and South America, Europe, Africa, and Asia
Enrolled individuals had a laboratory-confirmed diagnosis of SARS-CoV-2 infection
Mild to moderate symptoms
At least one characteristic or underlying medical condition
Randomized (1:1) to receive PAXLOVID™ or placebo orally every 12 hours for five days
About the Phase 2/3 EPIC-HR Study Safety Data
Safety data, n = 1881
Treatment-emergent adverse events
PAXLOVID™group
19%
Placebo group
21%
Most of which were mild in intensity
Fewer serious adverse events
PAXLOVID™group
1.7%
Placebo group
6.6%
Discontinuation of study drug due to adverse events
PAXLOVID™group
2.1%
Placebo group
4.1%
Pharmacology
Specifically designed SARS-CoV-2-3CL protease inhibitor,
an enzyme that the coronavirus needs to replicate
Co-administration with a low dose of ritonavir helps slow the metabolism of PF-07321332
PF-07321332 inhibits viral replication at a stage known as proteolysis,
which occurs before viral RNA replication
In preclinical studies, PF-07321332 did not demonstrate evidence of mutagenic DNA interactions.
EPIC-SR includes a cohort of vaccinated patients who have an acute breakthrough symptomatic COVID-19 infection and who have risk factors for severe illness.
