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Hyperbaric Oxygen Therapy for COVID-19 Patients: A Prospective, Randomized Controlled Trial

27 Pages Posted: 9 Apr 2021

See all articles by Amir Hadanny

Amir Hadanny

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Shachar Finci

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Merav Catalogna

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Ramzia Abu Hamed

Shamir (Assaf Harofeh) Medical Center - Research and Development Unit

Calanit Korin

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Levi Gabriella

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Katia Adler-Vallach

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Natalia Tarasula

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Mahgna Hamad

Tel Aviv University - School of Medicine

Zemer Wang

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Erez Lang

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Yonatan Zemel

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Yair Bechor

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Noami Rahimi-Levene

Tel Aviv University - School of Medicine

Yonatan Shapira

Tel Aviv University - School of Medicine

Oleg Gorelik

Tel Aviv University - School of Medicine

Irma Tzur

Tel Aviv University - School of Medicine

Eduard Ilgiyaev

Tel Aviv University - School of Medicine

Avi Mizrachi

Tel Aviv University - School of Medicine

Eli Shiloah

Tel Aviv University - School of Medicine

Yasmin Maor

Edith Wolfson Medical Center - Infectious Disease Unit

Osnat Lev-Zion Korach

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Shai Efrati

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

More...

Abstract

Introduction: The hallmarks of pulmonary derangement due to severe COVID-19 disease include hypoxemia and a dysregulated and excessive immune response, i.e. a "cytokine storm". Several case series reported on the beneficial effect of hyperbaric oxygen therapy (HBOT) on COVID-19 patients. The aim of the current study was to evaluate the effects of HBOT on COVID-19 patients using a prospective randomized controlled design.

Methods: Thirty-one severe COVID-19 inpatients, suffering from respiratory insufficiency in addition to at least one other risk factor, were randomized to HBOT or a control arms in a 2:1 ratio. Patients underwent baseline evaluations which included symptoms questionnaire, vital signs and blood tests. The HBOT arm patients underwent eight HBOT sessions twice daily. The evaluation was repeated on day 5, the day after the last HBOT session.

Results: Compared to the control group, one day following the last HBOT session, there was a significant increase in room air saturation in the HBOT patients (F=15·269, p=0·001), significant improvement in the NEWS severity score (F=16·379, p=0·001) and a decreased respiratory rate (F=15·269, p=0·001). There was a significant decrease in CRP and LDH in the HBOT group compared to the control group (CRP: F=5·322, p=0·032, LDH: F=5·599, p=0·027) and a significantly higher proportion developed COVID-19 IgG antibodies compared to the control group (p<0·001).

Conclusion: This study demonstrates, for the first time in a prospective randomized clinical trial, that HBOT is a safe therapeutic modality that can improve oxygenation, attenuate inflammation and improve the clinical status of severely ill COVID-19 patients. Larger scale studies are needed to evaluate the effect on inpatient mortality.

Trial Registration: The study was registered at clinicaltrials.gov NCT04358926.

Funding Statement: The study was supported by the research fund of Shamir
Medical Center.

Declaration of Interests: Amir Hadanny, Yair Bechor, Yonatan Zemel work for AVIV Scientific
LTD., Shai Efrati is a shareholder at AVIV Scientific LTD., all other authors have nothing to disclose.

Ethics Approval Statement: This study was approved by the Institutional Review Board (IRB) at Shamir Medical Center and the Israeli National Review Board.

Suggested Citation

Hadanny, Amir and Finci, Shachar and Catalogna, Merav and Abu Hamed, Ramzia and Korin, Calanit and Gabriella, Levi and Adler-Vallach, Katia and Tarasula, Natalia and Hamad, Mahgna and Wang, Zemer and Lang, Erez and Zemel, Yonatan and Bechor, Yair and Rahimi-Levene, Noami and Shapira, Yonatan and Gorelik, Oleg and Tzur, Irma and Ilgiyaev, Eduard and Mizrachi, Avi and Shiloah, Eli and Maor, Yasmin and Lev-Zion Korach, Osnat and Efrati, Shai, Hyperbaric Oxygen Therapy for COVID-19 Patients: A Prospective, Randomized Controlled Trial. Available at SSRN: https://ssrn.com/abstract=3745115 or http://dx.doi.org/10.2139/ssrn.3745115

Amir Hadanny (Contact Author)

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Shachar Finci

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Merav Catalogna

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Ramzia Abu Hamed

Shamir (Assaf Harofeh) Medical Center - Research and Development Unit ( email )

Zerifin
Israel

Calanit Korin

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Levi Gabriella

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research

Zerifin
Israel

Katia Adler-Vallach

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Natalia Tarasula

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Mahgna Hamad

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Zemer Wang

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Erez Lang

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Yonatan Zemel

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Yair Bechor

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Noami Rahimi-Levene

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Yonatan Shapira

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Oleg Gorelik

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Irma Tzur

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Eduard Ilgiyaev

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Avi Mizrachi

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Eli Shiloah

Tel Aviv University - School of Medicine ( email )

Ramat Aviv
Israel

Yasmin Maor

Edith Wolfson Medical Center - Infectious Disease Unit

Holon
Israel

Osnat Lev-Zion Korach

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

Shai Efrati

Shamir (Assaf Harofeh) Medical Center - Sagol Center for Hyperbaric Medicine and Research ( email )

Zerifin
Israel

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