Chinese Clinical Trial: Efficacy and Safety of Hyperbaric Oxygen Therapy to patients with novel coronavirus pneumonia (COVID-19)

According to the World Health Organization (WHO), researchers at the Sixth Medical Center of PLA General Hospital, in Bejing, China and the Wuhan Huoshenshan Hospital in Wuhan City, China have begun a clinical trial entitled, “Efficacy and Safety of Hyperbaric Oxygen Therapy to patients with novel coronavirus pneumonia (COVID-19).”

Objectives of Study：To correct tissue hypoxia and secondary pathophysiological damage in patients with COVID-2019 by hyperbaric oxygen therapy, and promote patient’s recovery.

Inclusion Criteria:

1. Aged >=18 years old;
2. Patients suspected of having COVID-2019 pneumonia who also have one of the following etiological or serological evidence.
   1. Real-time fluorescent RT-PCR detection of COVID-2019 nucleic acid positive;
   2. Viral gene sequencing, and Known novel coronaviruses are highly homologous;
   3. Serum novel coronavirus-specific IgM antibodies and IgG antibodies are positive; serum novel coronavirus-specific IgG antibodies change from negative to positive or the recovery period is 4 times higher than the acute period and increased high;
3. Ordinary patients have fever, respiratory tract and other symptoms, and imaging shows pneumonia;
4. Severe patients meet any of the following criterias:
   1. Shortness of breath, RR330 times / min;
   2. At rest, refers to oxygen saturation <=93%;
   3. Arterial blood oxygen partial pressure (PaO2) / aspiration Oxygen concentration (Fi02) <=300 mmHg (1 mmHg = 0.133 kPa);
   4. Pulmonary imaging showed that the lesions significantly progressed within 24-48 hours> 50% were managed as heavy.
5. No contraindications to hyperbaric oxygen therapy;
6. The patient and his family can sign the informed consent.

Exclusion Criteria：

1. Pregnancy or lactation;
2. Having a history of major diseases such as disorders of liver, kidney, endocrine or hematological systems;
3. Coagulation disorder;
4. Explicit history of tumors;
5. Having a history of malnutrition and cachexia;
6. Contraindicated by HBOT, such as pneumothorax, poor pressure adjustment of the eustachian tube, and internal hemorrhage;
7. Critically ill patients.

Interventions：

1. 1.5ATA Group: Intervention 1.5ATA HBO, Sample size：15
2. 2.5ATA Group:  Intervention: 2.5ATA HBO, Sample size：15
3. Control Group: Intervention: Routine Treatment, Sample size：15

Outcomes：

1. Oxygenation index
2. Activity endurance
3. IL-6 level
4. Blood routine biochemical indicators
5. Microparticle
6. CRP

Read the full study: http://www.chictr.org.cn/showproj.aspx?proj=52142