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28 oktober 2021: Bloedplasma geven aan al ernstig zieke patiënten besmet met het coronavirus - Covid-19 geeft geen verschil in ziekteverloop en kans op overlijden. Dit blijkt uit de resultaten van een grote fase III studie. 

Effect of Convalescent Plasma on Organ Support–Free Days in Critically Ill Patients With COVID-19

Conclusion: Among critically ill adults with confirmed COVID-19, treatment with convalescent plasma had a low likelihood of providing improvement in organ support–free days. (Bij ernstig zieke volwassenen met bevestigde COVID-19 had behandeling met herstellend plasma een lage kans op verbetering van orgaanondersteuningsvrije dagen.)

Abstract staat onderaan dit artikel

11 november 2020: Mooi nieuws voor kankerpatienten:

Nieuwe corona-behandeling met bloedplasma kan starten

Sanquin Bloedbank en plasmaproducent Sanquin Plasma Products (SPP) hebben de afgelopen maanden uit gedoneerd bloed 4.000 doses met antistoffen tegen het coronavirus geproduceerd. Dit medicijn is nu klaar om ingezet te worden. Het zal in eerste instantie worden toegepast om besmetting en ziekte bij mensen met een verzwakt immuunsysteem te voorkomen. Daarbij gaat het bijvoorbeeld om kankerpatiënten en mensen die net een transplantatie hebben ondergaan. Ook komt er een onderzoek om in kaart te brengen hoe effectief dit medicijn is om besmetting van kwetsbare ouderen te voorkomen, bijvoorbeeld na contact met een besmet persoon.>>>>>>>lees verder

14 oktober 2020: lees ook dit artikel: 

https://kanker-actueel.nl/nieuwe-studies-bewijzen-dat-een-besmetting-met-het-corona-virus-covid-19-langdurige-immuniteit-geeft-door-igm-en-iga-antistoffen-die-opgeslagen-worden-in-immuunsysteem.html

Lees ook dit artikel: 

https://kanker-actueel.nl/bloedplasma-met-antistoffen-bewijst-meer-en-meer-goed-te-werken-bij-patienten-besmet-met-het-corona-virus-covid-19.html

en dit artikel: 

https://kanker-actueel.nl/remdesivir-lijkt-klachten-veroorzaakt-door-coronavirus-covid-19-te-verminderen-maar-is-weinig-bewijs-voor.html

3 oktober 2020: Verschillende media

Dat de president van Amerika Donald Trump en zijn vrouw Melania besmet zijn met het coronavirus - Covid-19 zal niemand ontgaan zijn denk ik.  Dat Trump zelf inmiddels behandeld wordt met een bloedplasma coctail van antibodies - antistoffen naast remsidivir wordt ook al uitgebreid besproken in de internationale media. Opvallend toch wel dat hij ook aanvullend melatonine, vitamine D en aspirine krijgt en is al minder bekend denk ik. Al hebben Algemeen Dagblad enz dit wel overgenomen van CNN die dit als eersten vermelden omdat de arts van het Witte Huis dit verklaarde in een persmoment. 

Regeneron, de producent van de bloedplasma met antistoffen heeft toevallig enkele dagen geleden, nog voor bekend werd dat Trump besmet was een persbericht uitgegeven over de resultaten uit een studie met hun bloed[plasma coctail. Die inderdaad veelbelovend zijn maar nog niet onafhankelijk door andere wetenschappers zijn beoordeeld ( peer reviewed).

Op de website van Regeneron zijn de voorlopige resuslaten te lezen bij de eerste 250 patiënten, zie onderaan dit artikel: 

Science schreef er wel een artikel over: ‘Provocative results’ boost hopes of antibody treatment for COVID-19

Een tweede bedrijf heeft nu sterke aanwijzingen geproduceerd dat monoklonale antilichamen, synthetisch geproduceerde versies van eiwitten gemaakt door het immuunsysteem, kunnen werken als behandelingen bij mensen die besmet zijn met het pandemische coronavirus, maar nog niet ernstig ziek zijn.
De biotech Regeneron Pharmaceuticals heeft een cocktail ontwikkeld van twee monoklonale antilichamen die zich hechten aan het oppervlakte-eiwit van dat coronavirus, SARS-CoV-2, en proberen te voorkomen dat het cellen infecteert. Gisteren maakte het bedrijf tijdens een webcast voor investeerders en media de eerste resultaten bekend.

Het bedrijf toonde dia's met gedetailleerde gegevens van 275 geïnfecteerde mensen in een placebo gecontroleerde studie die uiteindelijk van plan is om 2100 asymptomatisch of, in het ergste geval, matig ziek te registreren.

De analyse verdeelt de patiënten in twee groepen: degenen die bij aanvang van het onderzoek detecteerbare antilichamen tegen SARS-CoV-2 hadden en degenen die dat niet deden, een zogenaamde seronegatieve groep. De monoklonale cocktail had weinig effect op mensen die al antistoffen tegen het virus hadden. Maar het leek de seronegatieve patiënten te helpen, door de hoeveelheid virus in nasofaryngeale uitstrijkjes krachtig te verminderen en de symptomen sneller te verlichten.

"Dit zijn hoopvolle en uitdagende resultaten", zegt Myron Cohen van de University of North Carolina, Chapel Hill.

Cohen merkt op dat de gegevens van Regeneron vergelijkbaar zijn met die in een persbericht van Eli Lilly twee weken geleden over vroege resultaten van een proef met zijn enkele monoklonale antilichaam tegen SARS-CoV-2. "Beide rapporten gaan in dezelfde richting", zegt Cohen. Maar hij waarschuwt dat geen van beide is gepubliceerd, beide onderzoeken zijn aan de gang en er zijn meer gegevens nodig om te begrijpen hoe - en of - deze experimentele geneesmiddelen patiënten het beste kunnen helpen. Vreemd genoeg zag Lilly geen effect bij de hoogste dosis antilichaam die werd getest, en Regeneron zag geen verschil tussen de preparaten met lage en hoge doses die in het onderzoek werden gebruikt. >>>>>lees verder het artikel in Science

Deze voorlopige resultaten maakte Regeneron bekend in dit artikel: 

The descriptive analysis included the first 275 patients enrolled in the trial and was designed to evaluate anti-viral activity with REGN-COV2 and identify patients most likely to benefit from treatment; the next cohort, which could be used to rapidly and prospectively confirm these results, has already been enrolled. Patients in the trial were randomized 1:1:1 to receive a one-time infusion of 8 grams of REGN-COV2 (high dose), 2.4 grams of REGN-COV2 (low dose) or placebo. All patients entering the trial had laboratory-confirmed COVID-19 that was being treated in the outpatient setting. Patients were prospectively characterized prior to treatment by serology tests to see if they had already generated antiviral antibodies on their own and were classified as seronegative (no measurable antiviral antibodies) or seropositive (measurable antiviral antibodies). Approximately 45% of patients were seropositive, 41% were seronegative and 14% were categorized as "other" due to unclear or unknown serology status.

Key data findings include:
Note that since this analysis was considered descriptive, all p-values are nominal.

  • As hypothesized, patients in the study consisted of two different populations: those who had already mounted an effective immune response, and those whose immune response was not yet adequate. These populations could be identified serologically by the presence (seropositive) or absence (seronegative) of SARS-CoV-2 antibodies, and/or by high viral loads at baseline.
  • Serological status highly correlated with baseline viral load (p<0.0001). Seropositive patients had much lower levels of virus at baseline, and rapidly achieved viral loads approaching lowest levels quantifiable (LLQ), even without treatment. In contrast, seronegative patients had substantially higher viral levels at baseline, and cleared virus more slowly in the absence of treatment.
  • Serological status at baseline also predicted how rapidly patients had alleviation of their COVID-19 clinical symptoms. In the untreated (placebo) patients, seropositive patients had a median time to alleviation of symptoms of 7 days, compared to seronegative patients who had a median time to alleviation of symptoms of 13 days.
  • REGN-COV2 rapidly reduced viral load through Day 7 in seronegative patients (key virologic endpoint). The mean time-weighted-average change from baseline nasopharyngeal (NP) viral load through Day 7 in the seronegative group was a 0.60 log10 copies/mL greater reduction (p=0.03) in patients treated with high dose, and a 0.51 log10 copies/mL greater reduction (p=0.06) in patients treated with low dose, compared to placebo. In the overall population, there was a 0.51 log10 copies/mL greater reduction (p=0.0049) in patients treated with high dose, and a 0.23 log10 copies/mL greater reduction (p= 0.20) in patients treated with low dose, compared to placebo.
  • Patients with increasingly higher baseline viral levels had correspondingly greater reductions in viral load at Day 7 with REGN-COV2 treatment. The mean log10 copies/mL reduction in viral load compared to placebo were as follows:
    -  Viral load higher than 105 copies/mL: high dose (-0.93); low dose (-0.86) (p=0.03 for both); approximately 50-60% reduction compared to placebo
    -  Viral load higher than 106 copies/mL: high dose (-1.55); low dose (-1.65) (p<0.002 for both); approximately 95% reduction compared to placebo
    -  Viral load higher than 107 copies/mL: high dose (-1.79); low dose (-2.00) (p<0.0015 for both); approximately 99% reduction compared to placebo
  • Patients who were seronegative and/or had higher baseline viral levels also had greater benefits in terms of symptom alleviation. Among seronegative patients, median time to symptom alleviation (defined as symptoms becoming mild or absent) was 13 days in placebo, 8 days in high dose (p=0.22), and 6 days in low dose (p=0.09). Patients with increasing viral loads at baseline had correspondingly increasing benefit in time to symptom alleviation.
  • There were a small number of medically-attended visits given that most non-hospitalized patients recover well at home. Patients in the seronegative group were at higher risk of medically-attended visits: 10 of the 12 medically-attended visits (defined as hospitalizations, or emergency room, urgent care or telemedicine visits for COVID-19) occurred in patients who were seronegative at baseline. In the seronegative group, 15.2% of placebo-treated patients, 7.7% of patients treated with high dose and 4.9% of patients treated with low dose required additional medical visits.
  • Both doses were well-tolerated. Infusion reactions were seen in 4 patients (2 on placebo and 2 on REGN-COV2). Serious adverse events occurred in 2 placebo patients, 1 low dose patient and no high dose patients. There were no deaths in the trial.

More than 2,000 people have been enrolled across the overall REGN-COV2 development program, and no unexpected safety findings have been reported by the Independent Data Monitoring Committee.

"Thank you to the global investigators, sites and patients who continue to work with us to conduct REGN-COV2 trials, especially given the unique challenges posed by the pandemic," said David Weinreich, M.D., Senior Vice President and Head of Global Clinical Development at Regeneron. "We plan rapidly to submit detailed results from this analysis for publication in order to share insights with the public health and medical communities. Regeneron continues to enroll patients in this trial and all other ongoing late-stage trials evaluating REGN-COV2."

Additional Trial Background
Among the first 275 patients, approximately 56% were Hispanic, 13% were African American and 64% had one or more underlying risk factors for severe COVID-19, including obesity (more than 40%). On average, patients were 44 years of age. In total, 49% of participants were male and 51% were female.

At least 1,300 patients will be recruited into the Phase 2/3 portion of the outpatient trial overall. Patients will be followed for 29 days, with viral shedding in the upper respiratory tract assessed approximately every 2-3 days in the Phase 2 portion of the trial and clinical endpoints assessed via investigator and patient-reported data throughout.

In addition to this trial in non-hospitalized patients, REGN-COV2 is currently being studied in a Phase 2/3 clinical trial for the treatment of COVID-19 in hospitalized patients, the Phase 3 open-label RECOVERY trial of hospitalized patients in the UK and a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. Recruitment in all 4 trials is ongoing.

Investor and Media Webcast Information
Regeneron will host a conference call and simultaneous webcast to share updates on REGN-COV2 today September 29, 2020 at 4:30 pm ET. To access the call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International). A link to the webcast may be accessed from the "Investors and Media" page of Regeneron's website at www.regeneron.com. A replay of the conference call and webcast will be archived on the Company's website and will be available for at least 30 days.

October 4, 2021

Effect of Convalescent Plasma on Organ Support–Free Days in Critically Ill Patients With COVID-19A Randomized Clinical Trial

Writing Committee for the REMAP-CAP Investigators
JAMA. Published online October 4, 2021. doi:10.1001/jama.2021.18178
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Key Points

Question  Does 2 units of ABO-compatible, high-titer convalescent plasma, administered to critically ill patients with COVID-19, improve organ support–free days up to day 21 (a composite end point of in-hospital mortality and the duration of intensive care unit–based respiratory or cardiovascular support)?

Findings  This international bayesian randomized clinical trial that included 2011 participants treated with 2 units of high-titer convalescent plasma, compared with no convalescent plasma, resulted in a posterior probability of futility of 99.4% for the primary outcome of organ support–free days up to day 21.

Meaning  Among critically ill adults with confirmed COVID-19, treatment with convalescent plasma had a low likelihood of providing improvement in organ support–free days.

Abstract

Importance  The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.

Objective  To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19.

Design, Setting, and Participants  The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021.

Interventions  The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916).

Main Outcomes and Measures  The primary ordinal end point was organ support–free days (days alive and free of intensive care unit–based organ support) up to day 21 (range, −1 to 21 days; patients who died were assigned –1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support–free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support–free days; cardiovascular support–free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events.

Results  Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support–free days was 0 (IQR, –1 to 16) in the convalescent plasma group and 3 (IQR, –1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group.

Conclusions and Relevance  Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support–free days.

Trial Registration  ClinicalTrials.gov Identifier: NCT02735707

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Plaats een reactie ...

1 Reactie op "Bloedplasma met antistoffen plus remsidivir plus aanvullend vitamine D, melatonine en aspirine moet president Donald Trump redden van het coronavirus - Covid-19"

  • Bert Boersma :
    Dr Bartlett uit Texas is er in geslaagd een I.C.-afdeling met honderden coronapatienten binnen 48 uur leeg te krijgen door de ontstekingsremmer BUDESONIDE via een vernevelaar in de longen in te brengen. In andere ziekenhuizen wordt dit ook toegepast en inmiddels zijn er ca. duizend patienten genezen verklaard. Dus blijkbaar zijn er meer wegen die naar Rome leiden.
    Ook een vriendin die al 6 weken hoestte en niet echt beter werd met een ander pufje vroeg haar huisarts om budesonide. Binnen een week was ze volledig hoestvrij.

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