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100% not need COVID hospitalization with fluvoxamine plus one other drug – Thailand RCT April 2024


Early treatment with fluvoxamine, bromhexine, cyproheptadine, and niclosamide to prevent clinical deterioration in patients with symptomatic COVID-19: a randomized clinical trial

eClinicalMedicine Volume 70, April 2024, https://doi.org/10.1016/j.eclinm.2024.102517

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Background
Repurposed drugs with host-directed antiviral and immunomodulatory properties have shown promise in the treatment of COVID-19, but few trials have studied combinations of these agents. The aim of this trial was to assess the effectiveness of affordable, widely available, repurposed drugs used in combination for treatment of COVID-19, which may be particularly relevant to low-resource countries.

Methods
We conducted an open-label, randomized, outpatient, controlled trial in Thailand from October 1, 2021, to June 21, 2022, to assess whether early treatment within 48-h of symptoms onset with combinations of fluvoxamine, bromhexine, cyproheptadine, and niclosamide, given to adults with confirmed mild SARS-CoV-2 infection, can prevent 28-day clinical deterioration compared to standard care. Participants were randomly assigned to receive treatment with fluvoxamine alone, fluvoxamine + bromhexine, fluvoxamine + cyproheptadine, niclosamide + bromhexine, or standard care. The primary outcome measured was clinical deterioration within 9, 14, or 28 days using a 6-point ordinal scale. This trial is registered with ClinicalTrials.gov (NCT05087381).

Findings
Among 1900 recruited, a total of 995 participants completed the trial. No participants had clinical deterioration by day 9, 14, or 28 days among those treated with

  • fluvoxamine plus bromhexine (0%),
  • fluvoxamine plus cyproheptadine (0%), or
  • niclosamide plus bromhexine (0%).

Nine participants (5.6%) in the fluvoxamine arm had clinical deterioration by day 28, requiring low-flow oxygen. In contrast, most standard care arm participants had clinical deterioration by 9, 14, and 28 days. By day 9, 32.7% (110) of patients in the standard care arm had been hospitalized without requiring supplemental oxygen but needing ongoing medical care. By day 28, this percentage increased to 37.5% (21). Additionally, 20.8% (70) of patients in the standard care arm required low-flow oxygen by day 9, and 12.5% (16) needed non-invasive or mechanical ventilation by day 28. All treated groups significantly differed from the standard care group by days 9, 14, and 28 (p < 0.0001). Also, by day 28, the three 2-drug treatments were significantly better than the fluvoxamine arm (p < 0.0001). No deaths occurred in any study group.
Compared to standard care, participants treated with the combination agents had significantly decreased viral loads as early as day 3 of treatment (p < 0.0001), decreased levels of serum cytokines interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-1 beta (IL-1β) as early as day 5 of treatment, and interleukin-8 (IL-8) by day 7 of treatment (p < 0.0001) and lower incidence of post-acute sequelae of COVID-19 (PASC) symptoms (p < 0.0001). 23 serious adverse events occurred in the standard care arm, while only 1 serious adverse event was reported in the fluvoxamine arm, and zero serious adverse events occurred in the other arms.

Interpretation
Early treatment with these combinations among outpatients diagnosed with COVID-19 was associated with lower likelihood of clinical deterioration, and with significant and rapid reduction in the viral load and serum cytokines, and with lower burden of PASC symptoms. When started very soon after symptom onset, these repurposed drugs have high potential to prevent clinical deterioration and death in vaccinated and unvaccinated COVID-19 patients.
 Download the PDF from VitaminDWiki


Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) is approved by the (FDA) for the treatment of obsessive-compulsive disorder...


VitaminDWiki – COVID-19 treated by Vitamin D - studies, reports, videos

As of March 31, 2024, the VitaminDWiki COVID page had:  trial results,   meta-analyses and reviews,   Mortality studies   see related:   Governments,   HealthProblems,   Hospitals,  Dark Skins,   All 26 COVID risk factors are associated with low Vit D,   Fight COVID-19 with 50K Vit D weekly   Vaccines   Take lots of Vitamin D at first signs of COVID   166 COVID Clinical Trials using Vitamin D (Aug 2023)   Prevent a COVID death: 9 dollars of Vitamin D or 900,000 dollars of vaccine - Aug 2023
5 most-recently changed Virus entries

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4 treatment/prevention charts by C19early.org (Fluvoxamine similar to Vitamin D)

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COVID prevention (methods with limited data have been deleted)
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Fluvoxamine and COVID - Lancet RCT Jan 2022

Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial
Lancet DOI:https://doi.org/10.1016/S2214-109X(21)00448-4

  • Gilmar Reis, PhD, Eduardo Augusto dos Santos Moreira-Silva, PhD, Daniela Carla Medeiros Silva, PhD, Prof Lehana Thabane, PhD, Aline Cruz Milagres, RN. Thiago Santiago Ferreira, MD, et al.

"Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital."
 Download the PDF from VitaminDWiki


42+ VitaminDWiki Virus pages have RCT in the title

This list is automatically updated

Items found: 43
Title Modified
Single 600,000 IU dose of nanoemulsion Vitamin D is safe and effective to fight COVID, even if delay until enter ICU – RCT May 2024 01 Jun, 2024
100% not need COVID hospitalization with fluvoxamine plus one other drug – Thailand RCT April 2024 16 Mar, 2024
COVID deaths cut in half by a single dose of 600,000 IU of Vitamin D - RCT Jan 2024 31 Jan, 2024
COVID fought by Vitamin D: OBSERVATIONS: YES, RCTs: NO - Dec 2023 15 Jan, 2024
COVID in hospital stopped by Vitamin D Receptor activators (curcumin, quercetin) – RCT June 2023 25 Jun, 2023
COVID 3X less likely if Xyilotol nasal spray 3X per day – RCT Dec 2022 24 Feb, 2023
COVID recovery 1.6X faster after 200,000 IU of Vitamin D RCT – Feb 2023 22 Feb, 2023
Long-COVID fatigue reduced by Vitamin C and l-Arginine in one month– RCT Nov 2022 24 Nov, 2022
Influenza infection 5X less likely if got vitamin D – small RCT Feb 2022 23 Oct, 2022
COVID in hospital fought by Vitamin D (25,000 IU daily for 4 days, then 25K weekly) - RCT – July 2022 02 Oct, 2022
Small Vitamin D doses for a short time never help (not improve vaccination in this case) – RCT Sept 2022 24 Sep, 2022
The challenges of a Vitamin D RCT – too many already taking it, etc. – Martineau Sept 2022 13 Sep, 2022
Risk of COVID not reduced by 3,200 IU of vitamin D during 6 months (no surprise) – RCT March 2022 09 Sep, 2022
Early COVID treatments rarely work 7 days after symptoms, this trial gave Vitamin D on 7th day – RCT May 2022 26 Jul, 2022
COVID children helped by Vitamin D, trial terminated: unethical to not give Vitamin D to all: – RCT July 2022 25 Jul, 2022
4X less likely to get COVID following 4,000 IU daily for a month – RCT April 2022 12 Jun, 2022
COVID hospital deaths reduced 2X by 8 days of UVB – pilot RCT May 2022 05 Jun, 2022
400,000 IU of vitamin D 3 days after COVID symptoms reduced 14 day mortality by 3X – Annweiler RCT May 2022 02 Jun, 2022
Loading dose of Vitamin D for patients hospitalized with COVID (140,000 IU) – RCT completed 2021 22 May, 2022
21 fewer days in hospital with ARDS (COVID) if 10,000 IU of Vitamin D daily after enter hospital – RCT April, 2022 18 Apr, 2022
Influenza vaccine antibodies not change with Vitamin D – 21 ng or 44 ng – RCT Feb 2019 22 Mar, 2022
Group achieving 30 ng (vs 26 ng) were 2X less likely to get COVID symptoms - RCT Jan 2022 31 Jan, 2022
Nutritional supplementation during COVID hospitalization helped - RCT - Jan 2022 30 Jan, 2022
Tested positive for COVID, taking probiotics stopped symptoms 5 days sooner - RCT Jan 2022 18 Jan, 2022
Nursing home vaccinated against Influenza, 800 IU of vitamin D daily cut infection rate in half – small RCT Oct 2021 04 Nov, 2021
COVID-19 appears reduced by Resveratrol plus 100K IU of vitamin D – Small RCT Sept 2021 27 Sep, 2021
COVID-19 defeated 3x faster by 420,000 IU Vitamin D nanoemulsion – RCT Nov 12, 2020 21 Sep, 2021
Vitamin D not help 10 days after COVID-19 symptoms - RCT March 2021 18 Sep, 2021
COVID-19 outpatients getting Quercetin nanoemulsion had excellent outcomes (Q increased Vitamin D in cells) – RCT – June 2021 30 Jul, 2021
5,000 U daily raised Vitamin D a bit and helped COVID-19 a bit – RCT June 2021 14 Jul, 2021
COVID-19 inflammation extinguished by 60,000 IU of vitamin D nanoemulsion daily for a week – RCT May 2021 22 May, 2021
COVID-19 ICU survival rate increased 7X by daily Omega-3 – RCT March 2021 18 Apr, 2021
Half the risk of Influenza -A in infants taking 1200 IU of vitamin D for 4 months – RCT Jan 2018 19 Mar, 2021
5X less likely to enter ICU with COVID-19 if get Calcifediol (semi-activated vitamin D) - RCT Feb 19, 2021 13 Feb, 2021
Severe COVID-19 not fought by vitamin D when given too late - RCT Nov 18, 2020 22 Nov, 2020
COVID-19 defeated by calcifediol form of Vitamin D in Spain - pilot RCT Aug 29, 2020 22 Nov, 2020
Swine flu not prevented by 2,000 IU of vitamin D daily (the upper limit at the time) – RCT 2014 30 Aug, 2020
Global Push for RCTs in COVID-19 - April 4, 2020 07 Apr, 2020
Vaccine antibody generation not change with Vitamin D – 21 ng or 44ng – RCT Feb 2019 08 Jan, 2020
Dengue virus prevented by a small amount of Vitamin D – RCT Nov 2019 26 Nov, 2019
Respiratory Virus risk reduced 35 percent by Vitamin D (14,000 IU weekly) – RCT Oct 2018 18 Oct, 2018
Influenza reduced by 1.7 with 1200 IU D3, also reduced related asthma by 6X – RCT May 2010 10 Jan, 2018
Influenza A: 5X reduction in first month (only) with 2,000 IU of vitamin D– RCT July 2014 14 Jul, 2014

Very comprehensive description of this study by Robin on Substack

Note: FDA refused Emergency Use of fluvoxamine in early 2021: "benefits didn’t outweigh the risks"

Steve Kirsch Substack March 2024

Attached files

ID Name Comment Uploaded Size Downloads
20983 Early.png admin 17 Mar, 2024 178.47 Kb 77
20982 Prophylaxis.png admin 17 Mar, 2024 140.50 Kb 79
20981 Efficacy vs cost.png admin 17 Mar, 2024 84.96 Kb 76
20978 Lancet fluvoxamine_CompressPdf.pdf admin 16 Mar, 2024 211.62 Kb 34
20977 Efficacy vs cost.png admin 16 Mar, 2024 84.03 Kb 23
20975 Time.png admin 16 Mar, 2024 109.26 Kb 79
20974 fluvoxamine.png admin 16 Mar, 2024 54.94 Kb 40
20973 fluvoxamine_CompressPdf.pdf admin 16 Mar, 2024 557.78 Kb 44