Advanced Immunomodulators No Additional Benefit for Inpatient COVID-19 Pneumonia

Hospital Too Late for these Drugs--Failure to Correctly Conceptualize the Disease Fatal for the ACTIV-1 IM Trial and Some of its Participants

By Peter A. McCullough, MD, MPH

From the onset of the pandemic, it was clear that COVID-19 was an illness characterized by viral replication, cytokine storm, and micro- and macro-thrombosis. When there was oxygen desaturation and visible “pneumonia” on imaging, that meant cytokine storm was ebbing and blood clotting was occurring in the lungs as shown by autopsy studies.

Because the NIH and big pharma have never been able to conceptualize the illness correctly, they keep striking out in randomized trials. The ACTIV-1 IM protocol randomized patients when it was far too late to one of three advanced immunomodulators (single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day) and found no differential improvement in the outcome with mortality for all groups being unacceptably high. In fact, all-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]).

O'Halloran JA, Ko ER, Anstrom KJ, Kedar E, McCarthy MW, Panettieri RA Jr, Maillo M, Nunez PS, Lachiewicz AM, Gonzalez C, Smith PB, de Tai SM, Khan A, Lora AJM, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Wen J, Silverstein A, O'Brien SM, Al-Khalidi HR, Maldonado MA, Melsheimer R, Ferguson WG, McNulty SE, Zakroysky P, Halabi S, Benjamin DK Jr, Butler S, Atkinson JC, Adam SJ, Chang S, LaVange L, Proschan M, Bozzette SA, Powderly WG; ACTIV-1 IM Study Group Members. Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA. 2023 Jul 10. doi: 10.1001/jama.2023.11043. Epub ahead of print. PMID: 37428480

The lesson learned here is that when the NIH research groups do not recognize how academic physicians have come to understand and treat the disease in the home, there is little chance a hospital protocol such as this would be successful. None of the 52 authors called, sought to discuss, or cited the pathophysiologic figure I published in 2020. This conceptualization guided the world on the principles of treatment and when they should be applied. Academic isolated oblivion, and misguided groupthink is a giant and deadly shortcoming in federally funded COVID-19 research.

O'Halloran JA, Ko ER, Anstrom KJ, Kedar E, McCarthy MW, Panettieri RA Jr, Maillo M, Nunez PS, Lachiewicz AM, Gonzalez C, Smith PB, de Tai SM, Khan A, Lora AJM, Salathe M, Capo G, Gonzalez DR, Patterson TF, Palma C, Ariza H, Lima MP, Blamoun J, Nannini EC, Sprinz E, Mykietiuk A, Alicic R, Rauseo AM, Wolfe CR, Witting B, Wang JP, Parra-Rodriguez L, Der T, Willsey K, Wen J, Silverstein A, O'Brien SM, Al-Khalidi HR, Maldonado MA, Melsheimer R, Ferguson WG, McNulty SE, Zakroysky P, Halabi S, Benjamin DK Jr, Butler S, Atkinson JC, Adam SJ, Chang S, LaVange L, Proschan M, Bozzette SA, Powderly WG; ACTIV-1 IM Study Group Members. Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA. 2023 Jul 10. doi: 10.1001/jama.2023.11043. Epub ahead of print. PMID: 37428480.

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